Automatically reloading suture passer devices and methods

ABSTRACT

Suture passers and methods of use. Described herein are suture passers preloaded with suture, including cartridges that couple to a suture passer to form a loaded suture passer; the suture passer may be operated to pass one or more lengths of suture without having to be manually reloaded. In particular, described herein are preloaded and automatically reloading apparatuses typically.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 15/289,054, filed Oct. 7, 2016, which is a divisional of U.S.patent application Ser. No. 14/572,485, filed Dec. 16, 2014, and titled“AUTOMATICALLY RELOADING SUTURE PASSER DEVICES AND METHODS”, U.S. Pat.No. 9,492,162 issued Nov. 15, 2016, which claims priority as acontinuation-in-part to PCT/US2014/030137, filed Mar. 17, 2014 andtitled “SUTURE PASSER DEVICES AND METHODS,” Publication No. WO2014/145381. Each of these applications is herein incorporated byreference in its entirety.

U.S. patent application Ser. No. 14/572,485 also claims priority to U.S.Provisional Patent Application No. 61/916,735, filed Dec. 16, 2013 andtitled “AUTOMATICALLY RELOADING SUTURE PASSER DEVICES AND METHODS.” Eachof these applications is herein incorporated by reference in itsentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The methods and apparatuses (e.g., devices and systems) described hereinmay be used to suture tissue, particularly in difficult to accessregions. In particular, described herein are preloaded and automaticallyre-loading suture passers, suturing techniques, and methods of operatingsuture passers for surgical use including repairing tissue. For example,described herein are suture passers that may be used for performingarthroscopic (including minimally invasive, e.g., endoscopic)procedures.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have beendeveloped to assist in accessing and treating internal body regions, andto generally assist a physician in repairing tissue. Although many suchdevices are available for endoscopic and/or percutaneous use, thesedevices suffer from a variety of problems, including limited ability tonavigate and be operated within the tight confines of the body, risk ofinjury to adjacent structures, problems controlling the position and/orcondition of the tissue before, during, and after passing the suture,and difficulties loading the suture into the device, particularly forthreading multiple suture loops.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

Some variations of suture passers, such as those described in U.S. Pat.No. 7,377,926 to Taylor, have opposing jaws that open and close overtissue. One, or in some variations, both, jaws open, scissor-like, sothat tissue may be inserted between the open jaws. Unfortunately, suchdevices cannot be adequately positioned for use in hard to navigate bodyregions such as the joints of the body, including the knee (e.g.,meniscus) and the shoulder because there is not room within the confinesof the body (e.g., joint region) to open the scissoring jaws.

The knee joint is one example of a tissue region that is notoriouslydifficult to access. For example, the meniscus is a C-shaped piece offibrocartilage which is located at the peripheral aspect of the joint(e.g., the knee) between the condyles of the femur and the tibia on thelateral and medial sides of the knee. The central two-thirds of themeniscus has a limited blood supply while the peripheral one thirdtypically has an excellent blood supply. Acute traumatic events commonlycause meniscus tears in younger patients while degenerative tears aremore common in older patients as the menisci become increasingly brittlewith age. Typically, when the meniscus is damaged, a torn piece ofmeniscus may move in an abnormal fashion inside the joint, which maylead to pain and loss of function of the joint. Early arthritis can alsooccur due to these tears as abnormal mechanical movement of tornmeniscal tissue and the loss of the shock absorbing properties of themeniscus lead to destruction of the surrounding articular cartilage.Occasionally, it is possible to repair a torn meniscus. While this maybe done arthroscopically, surgical repair using a suture has provendifficult to perform because of the hard-to-reach nature of the regionand the difficulty in placing sutures in a way that compresses andsecures the torn surfaces.

Arthroscopy typically involves inserting a fiberoptic telescope that isabout the size of a pencil into the joint through an incision that isapproximately ⅛ inch long. Fluid may then be inserted into the joint todistend the joint and to allow for visualization of the structureswithin that joint. Then, using miniature instruments which may be assmall as 1/10 of an inch, the structures are examined and the surgery isperformed.

The meniscus of the knee is just one example of a tissue that isdifficult to access so that appropriate suturing may be performed. FIG.2 illustrate the anatomy of the meniscus in the context of a knee joint.As shown in FIG. 2 the capsule region (the outer edge region of themeniscus) is vascularized. Blood enters the meniscus from themenisculocapsular region 291 lateral to the meniscus. A typical meniscushas a flattened bottom 298 (inferior surface or side adjacent to thetibia) and a concave top 296 (superior surface or side, adjacent to thefemur), and the outer cross-sectional shape may be somewhat triangular,with a meniscus tip region 294. The outer edge of the meniscustransitions into the capsule 291. The meniscus may includecircumferential fibers extending along the curved length of themeniscus, as well as radial fibers, and more randomly distributed meshnetwork fibers. Because of the relative orientations and structures ofthese fibers, and the predominance of circumferential fibers, it may bebeneficial to repair the meniscus by suturing radially (vertically)rather than longitudinally or horizontally, depending on the type ofrepair being performed. Most prior art devices for suturing or repairingthe meniscus are only capable of reliably repairingvertical/longitudinal tears. Such devices are not typically useful forrepairing radial or horizontal tears. Furthermore, prior art devicemechanisms have a high inherent risk for iatrogenic injury tosurrounding neurovascular structures and chondral surfaces.

Thus, there is a need for methods and apparatuses (e.g., devices andsystems) for suturing tissue, particularly tissue in difficult to accessregions of the body including the joints (shoulder, knee, etc.). Inparticularly, it has proven useful to provide a device that may simplyand reliably reach and pass sutures within otherwise inaccessible tissueregions. Such devices should be extremely low profile, and may beadapted or otherwise configured to fit in the tight spaces of thejoints. Finally, would be useful to provide suturing apparatuses thatallow selective and specific penetration of the tissue by both thetissue penetrator (needle element) and a jaw so that complex (includingright-angled) suturing patterns may be achieved.

There is also a need for methods and apparatuses for suturing tissue. Inparticular, it has proven useful to provide a device that may simply andreliably reach and pass sutures within otherwise inaccessible tissueregions. Further, there is a need for suture passers that can beautomatically loaded (or preloaded) pass multiple lengths (e.g., bights)of suture though the tissue without requiring that they be manuallyreloaded, either within the tissue or by withdrawing them from thetissue.

Although a suture passers that may be preloaded or reloadable with oneor more sutures have been suggested, these devices typically requiremanual loading, activation and control of the suture in order tooperate. See, e.g., U.S. Pat. No. 8,460,318 to Murray. Although suchdevices can be loaded with multiple sutures, they cannot be preloadedand/or automatically loaded or operated, and therefore cannot beincorporated as part of a cartridge for a suture passer. However, suturepassers that could pass two (or more) lengths of suture, including twoor more portions of the same suture, without requiring manual loading orreloading, would be highly advantageous, as they could increase the easeof suturing and reduce the time required for surgical procedures, aswell as elimination or reducing a possible source of operational error.

The preloaded suture passers, preloaded cartridges for suture passers,and methods of operating such apparatuses to repair tissue describedherein are capable of automatically passing a preloaded length of sutureand automatically preloading with a second length of suture. Theseapparatuses (e.g., devices, including suture passers, and cartridges forsuture passers, and systems of suture passers) and the methods ofoperating them described herein may be used to access difficult-to reachtissues.

The apparatuses and methods described herein may address the needs andpotential benefits briefly discussed above.

SUMMARY OF THE DISCLOSURE

Described herein are preloaded cartridges for suture passers, preloadedsuture passers, systems including preloaded suture passers and/orcartridges for suture passers, and methods of operating any of these topass multiple lengths or suture and/or repair tissue. In particular,described herein are preloaded cartridges in which a first length ofsuture is preloaded into the tissue penetrator (e.g., needle) and, afterpassing the first length of suture, the cartridge automatically appliestension to load a second length of suture into the tissue penetrator.The cartridge is typically configured to be fully-enclosed, though withopening from which the loaded tissue penetrator may be extended andretracted. The cartridge may be configured as a jaw for use with asuture passer, or may include a jaw region. The cartridge may be coupledto a durable (e.g., reusable) suture passer; the cartridge may bedisposable or recyclable. The cartridge may be coupleable to a suturepasser, and may be slideable or adjustable once on the suture passer.The suture passer may engage with the cartridge to control the positionof the jaw portion of the suture passer and/or the tissue penetrator.

In any of the apparatuses and methods described herein, the tissuepenetrator is preloaded with a first bight of suture in a sutureengagement portion of the tissue penetrator, and also includes a secondbight of suture positioned to be loaded into the tissue engagementportion when the first bight has been passed by the suture passer.Importantly, the apparatus includes a releasable hold securing a portion(such as an end region) of the suture to the tissue penetrator so thatthis portion of the suture can move with the tissue penetrator; slidingthe tissue penetrator may therefore tension (e.g., pull taught) a regionof suture between the portion held by the releasable hold and a secondbight of suture. If the suture engagement portion of the tissuepenetrator (needle) is empty, the tension can pull the second bight ofsuture into the tissue engagement region for automatically reloading thesecond bight into onto the tissue penetrator. The second bight of sutureis typically held in a suture holding region that remains fixed relativeto the tissue penetrator.

For example, a replaceable jaw cartridge that is preloaded with suture,for use with a suture passer device, may include: a jaw housingconfigured to releasably engage the suture passer device; a tissuepenetrator configured to slide distally and proximally within the jawhousing; a suture within the jaw housing, the suture comprising a firstbight region loaded in a suture engagement region at a distal end regionof the tissue penetrator, and a second bight region loaded in a sutureholding region within the jaw housing; and a releasable hold on thetissue penetrator that releasably secures a first end region of thesuture against the tissue penetrator; wherein the releasable hold isconfigured to hold the portion of the suture between the first endportion and the second bight region in tension when the tissuepenetrator is withdrawn proximally so that the second bight region isloaded into the suture engagement region after the first bight regionhas been removed from the suture engagement region.

In some variations the cartridge (including the second jaw, suture andtissue penetrator) can clip onto and off of a compatible suture passerassembly (e.g., that includes a first jaw, body and handle at theproximal end of the body). The suture cartridge may be replaceable(swapped in/out) while the suture passer assembly is re-useable withdifferent cartridges (e.g., durable). In some variations the cartridgeportion is not swappable, and may not even be a distinct element, butmay be integrated into the suture passer. Thus, in some variations aseparate cartridge is not used, but instead the suture passer includesan integrated housing in or near the second jaw, in which the tissuepenetrator, suture (e.g., first and second bights of suture), sutureholding region and releasable hold are housed. These variations may bereferred to as “integrated” preloaded and/or automatically reloadingsuture passers. In any of the apparatuses described herein, unless thecontext indicates otherwise, one or more aspects of a preloaded and/orautomatically reloading cartridge may be incorporated in a suture passerthat does not include a replaceable/removable cartridge, such as anintegrated preloaded/automatically reloading suture passer.

Any of the apparatuses described herein (including preloaded cartridges,systems using preloaded cartridges, or integrated preloaded suturepassers) may also include in the enclosure or housing holding the tissuepenetrator and suture, one or more suture management elements such asguides, funnels, storage regions, spools, etc. to direct or hold thesuture.

Any of the apparatuses described herein may include a deflection surfaceat or near an exit through the jaw housing, wherein the deflectionsurface is configured to deflect the tissue penetrator away from the jawhousing as the tissue penetrator slides distally out of the exit. Thetissue penetrator may be generally configured to exit laterally from theside of the second jaw (e.g., the replaceable jaw cartridge). The tissuepenetrator may be an elongate, thin, flat, or otherwise bendablestructure. The tissue penetrator may be a metal (e.g., a shape memoryalloy such as Nitinol) that is capable of being stored in a relativelystraight configuration, and deflected one or more times when passing alength of suture, then restored to the relatively straight configurationwhen retracted back into the jaw housing.

A jaw housing may be configured to completely enclose the suture andtissue penetrator until the tissue penetrator is extended from the jawhousing. The jaw housing may be completely closed or it may include oneor more openings. The jaw housing may include a region configured as ajaw. This jaw region may be configured to mate with another jaw regionof a suture passer, such as an upper or pivoting jaw; the two jaws mayform a distal-facing opening that can be opened and closed relative toeach other to partially surround and/or grip target tissue to besutured. Thus, the jaw housing may include a tissue-engaging surfacethat can be positioned opposite another jaw surface on the suturepasser. The tissue-engaging surface may be smooth, or it may include atexture or geometry that aids in grasping and/or holding tissue.

In variations in which the cartridge is replaceably coupleable to asuture passer, the suture passer may not be competent to pass suturewithout a cartridge attached; for example durable portion of the suturepasser may include a handle, controls, an elongate body and a fixed orrotatable upper jaw member, but may lack a lower jaw (e.g., a slidinglower jaw) and/or a tissue penetrator. Such suture passers may bereferred to herein as durable (or re-usable) suture passers, becausethey can be re-sterilized and reused, or generally used with multiplereplaceable jaw cartridges.

Thus, in some variations the cartridge includes elements that helpconnect the cartridge to the durable suture passer. For example, a jawhousing may include a keyed connector configured for coupling with anelongate member of the suture passer device.

In general, the apparatuses described herein include a holding region(suture holding region) for holding the second bight of suture that willbe automatically re-loaded into the suture engagement region of thetissue penetrator. For example, any of these apparatuses may include asuture holding region that is configured as a notched region between thetissue penetrator and an inner surface of the jaw housing. The sutureholding region may act in conjunction with the releasable hold on thetissue penetrator to hold the length of suture between the sutureholding region and the reliable hold in tension. In some variations thesuture holding region pinches or grasps the second bight region of thesuture. In other variations the suture holding region does not apply anyforce to the second bight region; because the second bight region bendsover/within the suture holding region (e.g., a notch forming the sutureholding region) the second bight region may be held in the sutureholding region.

In general, the suture holding region may be configured to be positionedopposite from the suture engagement region of the tissue penetrator whenthe tissue penetrator is withdrawn proximally within the jaw housing.Thus, tension on the second bight region (e.g. from the releasable hold)may allow it to slide from the suture holding region into the sutureengagement region when the first bight is no longer in the sutureholding region and when the tissue penetrator has been positioned withinthe housing to align the suture engagement region with the sutureholding region.

Any appropriate suture may be used, including synthetic, natural orhybrid sutures. The suture may be monofilament or woven, and may becoated or uncoated. Although in some variations different suture may beused, in general the first and second bights of suture may be formedfrom different regions of the same suture. For example, the first bightregion may be formed as a bend in the suture located near a distal endof the suture and the second bight region may be formed as a bend in thesuture located near the proximal end of the suture.

In general, a releasable hold is attached to the tissue penetrator andmoves with the tissue penetrator; the releasable hold typically holds anend region of a suture against the tissue penetrator as it moves andholds the end region relatively fixed to the tissue penetrator,providing tension to the pull the second bight suture to load it intothe tissue penetrator. If the force (tension) on this length of sutureexceeds a threshold (e.g., a release threshold), the releasable holdwill release the suture; in some variations the suture is not completelyreleased above the threshold, but the releasable hold continues to applya holding force to the end region of the suture that is less than therelease force. In some variations the releasable hold stops applying aholding force when the tension exceeds the release threshold. Anyappropriate releasable hold may be used. In general, the releasable holdholds a portion of the suture against the tissue penetrator (needle).The releasable hold may push, press, clamp, pinch, bind, or otherwisetemporarily secure the suture against the suture passer. For example, areleasable hold may comprise one or more of: an O-ring, a clip, afriction releasable hold, a band, a clamp, a frangible hold, a wax hold,and a releasable adhesive. The releasable hold may include multipleholding sites (e.g., two or more mechanical holding sites, a mechanicalholding site and an adhesive holding site, etc.). In general, thereleasable hold is positioned proximally on the tissue penetratorrelative to the suture engagement region (which may be positioned nearthe distal tip of the tissue penetrator); the spacing from the distaltip/suture engagement region is typically greater than the distancetraveled by the tip of the tissue penetrator so that the releasable holdremains within the housing during normal operation. Although thereleasable hold is typically configured to attached to and move with thetissue penetrator, so as to hold an end portion of the suture fixed tothe tissue penetrator, in some variations the releasable hold may slideor be moved on/along the tissue penetrator. In other variations thereleasably hold may be fixedly attached to the tissue penetrator.

The needle may also be adapted to help releasable secure a portion ofthe suture with the suture engagement region. For example, the tissuepenetrator may be bent or shaped to help pinch the suture against thereleasable hold. In some variations the region of suture may also beconfigured to engage the releasable hold (e.g., including a knot, aglet,ferrule, etc.).

Any component that couples with (and slides with) the tissue penetratormay be configured as a releasable hold. For example a needle sled (sled)may be configured as a releasable hold. In general, the tissuepenetrator within the apparatus may be a sled distally/proximally andextended from and retracted back into the jaw housing (e.g., lower jawhousing, cartridge housing, etc.). Thus, the jaw housing may alsoinclude/enclose a sled (e.g., needle sled) configured to couple with thetissue penetrator to facilitate sliding of the tissue penetrator withinthe jaw cartridge. In variations in which the jaw cartridge isreplaceably coupled to a durable suture passer, either or both thetissue penetrator and/or the needle sled may couple with a shaft in thedurable suture passer that is also connected to a control on a handleregion to control the sliding (extension/retraction) of the suturepasser. The needle engagement region may be a keyed region that allowspushing and/or pulling of the tissue penetrator within and out of/intothe housing. The needle may be actuated independently of any sliding ofthe jaw housing relative to the durable suture passer, in variations inwhich the jaw housing (forming a second or lower jaw) may be slide/movedaxially and distally relative to the other jaw member of the suturepasser. In some variation the needle and the lower jaw may be moved inconjugate motion.

The sled may be configured as a releasable hold, so that the releasableis part of the sled. For example, the sled may from one or more narrowgap regions into which an end portion of suture may be pinched againstthe body of the tissue penetrator when the tissue penetrator is coupledwith the sled and loaded with suture. In some variations the distal endportion of the sled comprise one or more such gap regions for holding anend portion of the suture. In some variations the sled is configured tocouple with the tissue penetrator and releasable hold the end portion ofthe suture against the tissue penetrator. The tissue penetrator may bebent or curved (e.g., by the sled) to help hold the end region of thesuture against the tissue penetrator.

In variations of the apparatus in which the tissue penetrator couplesdirectly to an actuator to slide the tissue penetrator, the engagementbetween the tissue penetrator and the actuator (push/pull rod, shaft,etc.) may be configured as a releasable hold. Alternatively, a separatereleasable hold may be coupled to the tissue penetrator.

The housing (e.g., jaw housing) may also include a storage region forstoring the length within the housing. For example, the apparatus mayinclude a suture capsule region configured to hold a portion of thesuture. The storage capsule region may be at the proximal end of theapparatus. For example, in variations in which the first and secondbight are formed of the proximal and distal end regions of a singlesuture, the region of suture between the first and second bight mayextend proximally along the shaft of the jaw housing to a suture capsuleat the proximal end that has an enlarged hollow allowing storage of thisintermediate region of suture until it is drawn out of the distal end ofthe housing when passing the suture to the opposite jaw.

In variations in which the jaw housing is configured as part of acartridge, the apparatus may include a connector configured to couplethe jaw cartridge to the suture passer device and to uncouple the jawcartridge from the suture passer device. For example, the jaw housingmay include keyed regions, such as one or more projections (e.g.,flanges, pins, bumps, etc.), to engage with a recess region in thedurable suture passer device, or one or more receiving regions (e.g.,channels, slots, etc.) to receive projecting portions of the suturepasser device, or both.

In some variations, the jaw cartridge includes a suture guide within thejaw housing positioned intermediate of the distal end of the jaw housingand the releasable hold. For example, the housing may include or hold afunnel or channel in which the suture passes, which may help guide thesuture so that the movement of the tissue penetrator within the housingdoes not undesirably engage (e.g., tangle) the suture.

As mentioned, the jaw housing and/or the entire jaw cartridge mayslideably engage with a durable suture passer device so that jaw memberportion of the jaw housing slides distally to proximally along the longaxis of the suture passer, in contrast with and independently of anupper jaw on the durable suture passer, which in some variations pivotsrelative to the long (distal-to-proximal) axis. For example, the jawhousing may be configured to couple to and uncouple from a durablesuture passer to form a sliding lower jaw member on the suture passer sothat the tissue penetrator can extend from the jaw housing to an upperjaw member.

For example, a replaceable jaw cartridge that is preloaded with suture,for use with a suture passer device, may include: an elongate jawhousing from a distal end to a proximal end in a first axis; a keyedregion of the jaw housing configured to releasably engage the suturepasser device; a tissue penetrator configured to slide distally andproximally within the jaw housing; an exit through the jaw housing nearthe distal end; a deflection surface near the exit configured to deflectthe tissue penetrator away from the first axis as it slides distally outof the exit; a suture within the jaw housing, the suture comprising afirst bight region loaded in a suture engagement region at a distal endregion of the tissue penetrator, and a second bight region loaded in asuture holding region within the jaw housing; and a releasable hold onthe tissue penetrator that releasably secures a first end region of thesuture against the tissue penetrator and is configured to slide with thetissue penetrator; wherein the releasable hold is configured to hold theportion of the suture between the first end portion and the second bightregion in tension when the tissue penetrator is withdrawn proximally sothat the second bight region is loaded into the suture engagement regionafter the first bight region has been removed from the suture engagementregion. Any of the features described above may be incorporated intothis variations. For example, the jaw housing may be configured tocompletely enclose the suture and tissue penetrator until the tissuepenetrator is extended from the jaw housing. The keyed region maycomprise a keyed connector configured for coupling within a track regionof an elongate member of the suture passer device.

Also described herein are suture passer systems with a preloaded suture,the system comprising: an elongate body extending distally andproximally; a first jaw coupled to a distal end of the elongate body;and a second jaw, the second jaw housing: a tissue penetrator configuredto slide distally and proximally within the second jaw, a suture withinthe second jaw, the suture comprising a first bight region loaded in asuture engagement region at a distal end region of the tissuepenetrator, and a second bight region loaded in a suture holding regionwithin the second jaw, and a releasable hold on the tissue penetratorconfigured to hold a first end portion of the suture in tension when thetissue penetrator is withdrawn proximally so that the second bightregion is drawn into the suture engagement region after the first bightregion has been removed. The first jaw may be configured to pivotrelative to the elongate body. The second jaw may be configured to slidedistally and proximally relative to the elongate body.

In some variations, the second jaw comprises a replaceable jaw cartridgeconfigured to releaseably engage with the elongate body so that the jawcartridge may slide distally and proximally relative to the elongatebody. For example, the second jaw may include a replaceable jawcartridge configured to releaseably engage with the elongate body sothat the jaw cartridge may slide distally and proximally relative to theelongate body. The second jaw may be configured to completely enclosethe suture and tissue penetrator until the tissue penetrator is extendedfrom the second jaw. The second jaw may include a keyed connectorconfigured for coupling the second jaw with the elongate body.

The system may also include a deflection surface near an exit throughthe second jaw, wherein the deflection surface is configured to deflectthe tissue penetrator away from the second jaw and towards the first jawas the tissue penetrator slides distally out of the exit.

As mentioned above, the suture holding region may comprise a notchedregion between the tissue penetrator and an inner surface of the jawhousing. The suture holding region may be configured to be positionedopposite from the suture engagement region of the tissue penetrator whenthe tissue penetrator is withdrawn proximally within the second jaw.

Also as described above, the first bight region may be located near adistal end of the suture and the second bight region is located near theproximal end of the suture. Any of the releasable holds discussed abovemay be used. For example, the releasable hold may comprise one or moreof: sled, an O-ring, a clip, a friction releasable hold, a band, aclamp, a frangible hold, a wax hold, and a releasable adhesive.

The system may also include a sled configured to couple with the tissuepenetrator to facilitate sliding of the tissue penetrator within thesecond jaw. The sled may be configured as (or may include) a releasablehold. The sled may couple the tissue penetrator with a driver (rod,shaft, etc.) on the suture passer for actuating the tissue penetrator.The system may also include a suture capsule region configured to hold aportion of the suture. The system may also include a releasableconnector configured to couple the second jaw to the suture passer andto uncouple the jaw cartridge from the suture passer. The system (or anyof the apparatuses described herein) may include a suture guide withinthe second jaw positioned intermediate of the distal end of the jawhousing and the releasable hold. The second jaw may comprise a housingthat is configured to couple to and to uncouple from a suture passer toform a sliding lower jaw on the suture passer.

Also described herein are systems for multiply suturing tissue with areplaceable, preloaded jaw cartridge, the system comprising: an elongatebody extending distally and proximally; a first jaw coupled to a distalend of the elongate body and configured to pivot relative to theelongate body; and a replaceable jaw cartridge configured to releaseablyengage with the elongate body so that the jaw cartridge may slidedistally and proximally relative to the elongate body, the jaw cartridgehousing: a tissue penetrator configured to slide distally and proximallywithin the jaw cartridge, a suture within the jaw cartridge, the suturecomprising a first bight region loaded in a suture engagement region ata distal end region of the tissue penetrator, and a second bight regionloaded in a suture holding region within the jaw cartridge, and areleasable hold on the tissue penetrator configured to hold a first endportion of the suture in tension when the tissue penetrator is withdrawnproximally so that the second bight region is drawn into the sutureengagement region after the first bight region has been removed.

Also described herein are methods of operating any of the apparatusesdescribed. For example, described herein are methods of operating asuture passer that is preloaded with a suture. A method of operating asuture passer may include: forming a distal-facing opening between afirst jaw of the suture passer and a second jaw; extending a distal tipof a tissue penetrator across the distal-facing opening from within thesecond jaw, wherein the tissue penetrator comprises a suture engagementregion that is preloaded with a first bight region of the suture;retracting the distal tip of the tissue penetrator into the second jaw;withdrawing the tissue penetrator distally within the second jaw totension the suture between an end region of the suture that is held by areleasable hold on the tissue penetrator and a second bight region ofthe suture, so that the second bight region is drawn into the sutureengagement region of the tissue penetrator; and extending the distal tipof the tissue penetrator from the second jaw and across thedistal-facing opening, wherein the tissue penetrator is carrying thesecond bight region of the suture.

The method may also include coupling a replaceable second jaw,configured as a jaw cartridge, to an elongate body of the suture passer,wherein the suture passer includes a first jaw pivotally coupled to adistal end region of the elongate body.

The step of forming a distal-facing opening between the first jaw of anda second jaw may comprise sliding the second jaw distally relative tothe elongate body to form the distal-facing opening between a distal endregion of the second jaw and the first jaw.

The method may also include uncoupling the jaw cartridge from the suturepasser.

In some of the methods of operating the apparatuses described herein,the method may also include pivoting the first jaw relative to theelongate body and sliding the second jaw distally to form thedistal-facing opening, and/or passing the first bight region of thesuture to the first jaw.

For example, described herein are methods of operating a suture passerthat is preloaded with a suture, the method comprising: coupling areplaceable jaw cartridge to an elongate body of the suture passer,wherein the suture passer includes a first jaw pivotally coupled to adistal end region of the elongate body, further wherein the jawcartridge comprises a second jaw; forming a distal-facing openingbetween the pivotally coupled first jaw of the suture passer and thesecond jaw by sliding the second jaw distally relative to the elongatebody to form a distal-facing opening between a distal end region of thesecond jaw and the first jaw; extending a distal tip of a tissuepenetrator from within the second jaw and across the distal-facingopening, wherein the tissue penetrator comprises a suture engagementregion that is preloaded with a first bight region of the suture;retracting the distal tip of the tissue penetrator into the second jaw;withdrawing the tissue penetrator distally within the second jaw totension the suture between an end region of the suture that is held by areleasable hold on the tissue penetrator and a second bight region ofthe suture, so that the second bight region is drawn into the sutureengagement region of the tissue penetrator; and extending the distal tipof the tissue penetrator from the second jaw and across thedistal-facing opening, wherein the tissue penetrator is carrying thesecond bight region of the suture.

Also described herein are methods of operating a surgical suturingapparatus, the method comprising: coupling a replaceable jaw cartridgeto an elongate body of a suture passer, wherein the suture passerincludes a first jaw pivotally coupled to a distal end region of theelongate body and wherein the jaw cartridge comprises a second jaw;pivoting the first jaw relative to the elongate body; sliding the secondjaw distally relative to the elongate body to form a distal-facingopening between the distal end region of the second jaw and the firstjaw; extending a distal tip of a tissue penetrator from within thesecond jaw and across the distal-facing opening, wherein the tissuepenetrator comprises a suture engagement region that is preloaded with afirst bight region of the suture; passing the first bight region of thesuture to the first jaw; retract the distal tip of the tissue penetratorinto the second jaw and withdrawing the tissue penetrator distallywithin the second jaw to tension the suture between an end region of thesuture that is held by a releasable hold on the tissue penetrator and asecond bight region of the suture, so that the second bight region isdrawn into the suture engagement region of the tissue penetrator;extending the tissue penetrator from the second jaw and across thedistal-facing opening, wherein the tissue penetrator is carrying thesecond bight region of the suture within the suture engagement region;and retracting the distal tip of the tissue penetrator into the secondjaw; and removing the jaw cartridge from the elongate body.

As described, in general the apparatuses (device and/or systems)described herein may be configured so that they can pass more than onelength of suture through the tissue sequentially. It may be beneficialto form a loop of suture around a tissue or tear in a tissue. Thus, thedevice may be configured to pass a first end of the suture and then(without removing the suture from the tissue) pass the second (opposite)end of the suture at a different location on the tissue, thereby forminga loop of suture which can be tied off by tying the ends of the suture(suture bights) to each other or to a device after they've been passed.

Thus, in general, described herein are suture passer devices having abent or bendable first jaw extending from an elongate body, and a secondjaw that is independently axially slideable relative to the elongatebody (and/or first jaw) to form a distal-facing opening between thefirst and second jaws into which target tissue may be held and suturedby extending a tissue-penetrator (e.g., needle) between the first andsecond jaws. As discussed above, these devices may be configured to passa suture multiple times through the tissue (e.g., passing both first andsecond ends of a suture) to create an entire loop of suture around atissue such as a torn meniscus. Further, this device may be adapted foruse with loops, snares, baskets and other suture passing aids.

The devices described herein may be adapted to include an indicator(e.g., optical indicator) showing where the tissue penetrator (e.g.,needle) of the suture passer will pass through a tissue and/or willengage with the opposite (e.g., upper) jaw of the suture passer. In somevariations, the suture passers describe herein are adapted so that thelower jaw moves axially both independently, e.g., to retract/extend forpositioning around a target tissue, and in conjunction with closing ofthe jaws, e.g., upper jaw motion, around tissue so that the needleextending from the lower jaw contacts with the upper jaw in apredictable fashion.

Also described herein are suture passers that provide a tactile and/oraudible feedback to the user when the tissue penetrator element isextended (e.g., fully extended).

Also described herein are suture passers that have extremely lowprofiles. In some variations the devices are adapted so that the lowerjaw has a substantially lower profile by reducing the arc of the needleexit, by axially separating the lower jaw into a first (e.g., proximal)region controlling the axial translation (motion) of the lower jaw and asecond (e.g., distal) region that contains all of the features of thetissue penetrator pathway; these different regions may have differentheights, allowing nesting into the shaft particularly near the proximalend of the device.

Although this disclosure is divided up into parts, indication differentfeatures, any of these parts or individual features may be used alone orin combination with any other parts or features described herein orincorporated by reference.

In general, the first or second jaw may hold the tissue penetratorwithin an internal passage, and the tissue penetrator may be extendedbetween the distal-facing opening to push and/or pull a suture betweenthe first and second jaws. The tissue penetrator may be any appropriatematerial, but shape memory materials (e.g., shape memory alloys,plastics, etc.) are of particularly interest. The tissue penetrator mayhave a sharp (e.g., pointed, beveled, etc.) distal tip for penetratingtissue, which may be symmetric (e.g., having a central sharp point inthe mid-line of the long axis) or asymmetric (having a sharp point thatis not in the mid-line of the tissue penetrator). The tissue penetratormay be biased (e.g., pre-bent) in a curve or bend. In general the tissuepenetrator (e.g., needle) may extend from a side region of the first orsecond jaw, extend across the distal-facing opening, and connect to anopening on the side region of the opposite (e.g., second or first) jawfrom which it extends. This opening may include a suture capture regionthat holds the suture passed by the tissue penetrator. The suturecapture region may be a suture retainer that holds the suture whenpassed by the tissue penetrator. For example, the suture retainer may bea deflecting or deflectable clamping region, a hook, or the like.

In general, the tissue penetrator may be configured to bend as itextends from the jaw and across the distal-facing opening. For example,the tissue penetrator may be pre-biased to assume a bent or curvedconfiguration as it extends from within a jaw. Thus, the tissuepenetrator may extend approximately perpendicular to the side of the jawhousing it. In some variations the jaw includes a tissue penetratordeflection (e.g., ramped) region that helps deflect the jaw. In somevariations the jaw housing the tissue penetrator does not include adeflector.

For example, described herein are suture passers for forming a loop ofsuture around a target tissue, the suture passer comprising: an elongatebody extending distally and proximally along a long axis; a first jawextending from a distal end region of the elongate body wherein thefirst jaw is bent or bendable at an angle relative to the long axis; asecond jaw configured to slide axially along the long axis distally andproximally relative to the elongate body, further wherein the first jawand the second jaw form a distal-facing opening when the second jaw isextended distally and wherein the second jaw is retractable proximallyso that it does not form the distal- facing opening with the first jaw;a tissue penetrator configured to extend across the distal-facingopening between the first jaw and the second jaw to pass a suture therebetween; and a plate having a keyhole capture region, wherein thekeyhole capture region comprise a capture pathway including a channelextending through the plate and a release pathway, wherein the capturepathway is connected to the release pathway by at least one bend,further wherein the plate is coupled to the first jaw so that it mayreceive a suture from the tissue penetrator extending from the secondjaw. The capture pathway may comprise an opening mouth at an edge of theplate that tapers to a narrower channel before the release pathway. Insome variations, the release pathway comprises an enlarged openinghaving a larger diameter than the region of the capture pathway adjacentto the release pathway. The bend may be configured to retain the sutureimmediately after it is passed into the keyhole capture region by thetissue penetrator.

In some variations, the plate is configured as a suture stripper.

The device may also include a suture having an enlarged distal endregion configured to be retained by the keyhole capture region, furtherwherein the diameter of the enlarged distal end region is greater thanthe diameter of the capture pathway but less than the diameter of aportion of the release pathway. The enlarged distal end region maycomprise a knot.

Also described herein are methods of passing a loop of suture around atarget tissue, the method comprising: placing a first jaw of a suturepasser adjacent to a first side of a target tissue, wherein the firstjaw extends from a distal end of an elongate body of the suture passer;extending a second jaw of a suture passer adjacent to a second side ofthe target tissue to form a distal-facing mouth with the first jaw,wherein the second jaw extends in a distal direction from the distal endof the elongate body of the suture passer; extending a tissue penetratorbetween the first and second jaws of the distal facing mouth whilepushing a capture member connected to a suture with the tissuepenetrator; retracting the tissue penetrator without the capture memberor suture back between the first and second jaws of the distal facingmouth; repositioning the first and second jaws relative to the targettissue; extending the tissue penetrator between the first and secondjaws of the distal facing mouth and capturing the capture member withthe tissue penetrator; and retracing the tissue penetrator with thecapture member back between the first and second jaws of the distalfacing mouth.

The step of placing the first jaw may comprise placing the first jawadjacent to the target tissue with the second jaw retracted proximallyso that the distal end of the second jaw is adjacent or proximal to thedistal end of the elongate body of the suture passer.

In some variations, the step of placing the first jaw comprises bendingthe first jaw relative to the elongate body.

Extending the tissue penetrator between the first and second jaws of thedistal facing mouth while pushing a capture member may include extendingthe tissue penetrator from the second jaw to the first jaw. Extending atissue penetrator between the first and second jaws of the distal facingmouth while pushing a capture member may comprise pushing a capturemember comprising a flexible loop wherein the suture is connected to theflexible loop, or a plurality of flexible loops. Extending a tissuepenetrator between the first and second jaws of the distal facing mouthwhile pushing a capture member connected to a suture with the tissuepenetrator may comprise extending the capture member from a distal endof the first jaw member.

Also described herein are suture passer devices for passing a suture,the device comprising: an elongate body extending distally andproximally along a long axis; a first jaw extending from a distal endregion of the elongate body wherein the first jaw is bendable at anangle relative to the long axis; a second jaw having a sharp, tissuepenetrating distal tip, wherein the second jaw is configured to bemanually slid axially along the long axis distally and proximallyrelative to the elongate body, further wherein the first jaw and thesecond jaw form a distal-facing opening when the second jaw is extendeddistally and wherein the second jaw is retractable proximally so that itdoes not form the distal-facing opening with the first jaw; a tissuepenetrator configured to extend across the distal-facing opening betweenthe first jaw and the second jaw to pass a suture there between; and acam surface coupled to the second jaw and configured to move the secondjaw axially in conjugate motion with bending of the first jaw member.The cam surface may be coupled with a trigger control configured tochange the bend angle of the first jaw relative to the long axis. Insome variations, the device further includes a control to engage ordisengage the camp surface and engage or disengage the conjugate motion.

Also described herein are suture passer device for passing a suture andproviding feedback to the user, the device comprising: an elongate bodyextending distally and proximally along a long axis; a first jawextending from a distal end region of the elongate body wherein thefirst jaw is bent or bendable at an angle relative to the long axis; asecond jaw having a sharp, tissue penetrating distal tip, wherein thesecond jaw is configured to slide axially along the long axis distallyand proximally relative to the elongate body, further wherein the firstjaw and the second jaw form a distal-facing opening when the second jawis extended distally and wherein the second jaw is retractableproximally so that it does not form the distal-facing opening with thefirst jaw; a tissue penetrator configured to extend across thedistal-facing opening between the first jaw and the second jaw to pass asuture there between; and an audible feedback actuator configured toprovide an audible signal when the tissue penetrator is fully extendedacross the distal-facing opening.

Also described herein are apparatuses and method of operating them thatinclude are devices having a jaw that is adapted to fit into a tightregion of the body such as the knee joint, and particularly around themeniscus of the knee. The jaw member (e.g., upper jaw member) may beadapted to be bent (e.g., hinged) relative to a long axis of the (e.g.,elongate body of the) apparatus, and may include a proximal regionclosest to the end of the jaw hinged to the elongate body of theapparatus that is curved on an upper distally-extending surface and isrelatively flat on the lower distally-extending surface that contactsthe tissue. The flat lower surface may prevent the tissue from beingforced out from between the jaws as the upper jaw is closed towards alower jaw; the curved upper surface may allow the upper jaw member to bepositioned easily between the target tissue and a curved bone surfacesuch as the femur (e.g., the head region of the femur).

Tissue penetrators (e.g., needles) may also or alternatively be adaptedso that the distal tip region is sharp and tissue-penetrating, and isprotected (e.g., shielded or covered) relative to a central loadingregion that extends longitudinally through the jaw member (e.g., lowerjaw member) when the tissue penetrator is retracted into the deviceprior to being extended. Thus, the sharp distal tip of the needle may belocated slightly displaced relative to the middle of the width of thetissue penetrator at the distal end of the tissue penetrator (e.g.,offset by between about 1% and about 40% of the midline of the midlineof the width of the tissue penetrator, e.g., between about 1%, 2%, 3%,4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 15%, 20%, or 24% and about 25%, 30%,35%, 40% of the midline of the width of the tissue penetrator).

Any of the apparatuses described herein may include a tissue penetratorthat include a distal sharp tissue penetrator region that includes aside opening into a suture retaining region that is located justproximal to the distal tip; the proximal portion of the side opening maybe curved towards the proximal end of the tissue penetrator, so that thewidth of the side opening gradually increases to the overall width ofthe tissue penetrator as the outer edge of the side opening extendsproximally. This configuration may prevent tissue from snagging orcatching on this lower (proximal) edge region of the side opening whenextending the tissue penetrator distally through the tissue.

As mentioned above, any of the apparatuses described herein may includesome or all of the features described and illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows one variation of a suture passer having a bent/bendableupper jaw and a lower jaw that slides axially (distal-to-proximal) inthe long axis, with the lower jaw retracted.

FIG. 1B shows a close-up of the distal end FIG. 1A with the lower jawextended. The suture passer in FIGS. 1A and 1B may include an integratedpreloaded and automatically reloading suture.

FIGS. 1C and 1D show side perspective views of an example of a suturepasser apparatus formed of a reusable/durable suture passer assemblyincluding the upper (pivoting) jaw, elongate body and handle withcontrols, to which a preloaded and automatically reloading cartridgeforming the lower jaw assembly has been attached. In FIG. 1C thecartridge is coupled to the suture passer assembly and the lower jaw isfully retracted (thus the cartridge is fully retracted). In FIG. 1D thesame suture passer apparatus is shown with the lower jaw extended toform a distal-facing opening between the upper jaw and the lower jawregion of the cartridge.

FIG. 2 illustrates the anatomy of the meniscus, including the capsuleand associated vascular tissue.

FIG. 3A shows an example of a suture passer assembly (which may beconfigured as a reusable/durable suture passer assembly) such as the oneshown in FIGS. 1C and 1D without a cartridge attached.

FIG. 3B shows a cartridge (including a lower jaw housing, tissuepenetrator, and suture) that is configured to be preloaded andautomatically reloading the suture.

FIG. 3C shows the suture passer assembly of FIG. 3A being coupled to thecartridge of FIG. 3B.

FIG. 4A shows an enlarged isometric view of one example of a pre-loadedand automatically reloading cartridge.

FIG. 4B shows an exploded view of the cartridge of FIG. 4A.

FIGS. 5A-5C show top, side perspective and side views, respectively, ofthe distal end of a preloaded and automatically reloadable cartridgesuch as the one shown in FIG. 4A.

FIG. 6 is an exploded view of a distal end region of one variation of apreloaded and automatically reloadable cartridge.

FIG. 7A shows an enlarged view of the distal end region of a preloadedand automatically reloadable cartridge such as the one shown in FIGS.5A-5C.

FIG. 7B shows an enlarged view of the cartridge housing for thepreloaded and automatically reloadable cartridge of FIG. 7A.

FIG. 7C is a partial perspective view, with some of the componentsremoved or made partially transparent, showing the relationship betweenthe tissue penetrator, suture and releasable hold, lower jaw housing,and top of one variation of a preloaded and automatically reloadablecartridge such as the one shown in FIGS. 7A and 7B.

FIG. 8 shows a tip view of one example of a tissue penetrator holding afirst bight of suture in a suture engagement region, where the suturealso include a second bight region that can be held in a suture holdingregion so that it doesn't move with the tissue penetrator, although thedistal end region of the suture near the second bight is held on thetissue penetrator by a releasable hold so that this end of the suturemoves with the tissue penetrator.

FIGS. 9A and 9B show side perspective and front views, respectively, ofone variation of a releasable hold that may be used with a preloaded andautomatically reloadable cartridge; in this example, the releasable holdis configured as a c-shaped clamp that attaches to the tissue penetratorin a predetermined (notched) position, as illustrated in FIGS. 9C and9D, showing top and bottom perspective views, respectively, or thisvariation of a releasable hold attached onto a tissue penetrator.

FIGS. 10A and 10B show side perspective and front views, respectively,of one variation of a releasable hold that may be used with a preloadedand automatically reloadable cartridge; in this example, the releasablehold is a c-shaped clamp that may be attached anywhere along the lengthof the tissue penetrator.

FIGS. 10C and 10D show top and bottom perspective views (respectively)of a tissue penetrator and suture to which this releasable hold has beenattached to hold the suture against the tissue penetrator as shown inFIG. 10C.

FIG. 11A is another variation of a preloaded and automaticallyreloadable cartridge from a top view. The reloadable cartridge includesa sled (needle sled) configured as the releasable hold.

FIG. 11B is a top perspective view of the releasable sled from thevariation shown in FIG. 11A.

FIG. 11C shows the releasable hold region of the sled, where the sled isconnected to a tissue penetrator and is holding an end region of asuture against the tissue penetrator.

FIG. 11D is an exploded view of another variation of a preloaded andautomatically reloadable cartridge including a sled integrated with areleasable hold for securing an end of a suture to the tissue penetratorso that the tissue penetrator may be automatically reloaded with asecond bight of suture after passing a first bight of suture.

FIGS. 12A-12C illustrate side perspective, top and side views,respectively of a proximal end of a preloaded and automaticallyreloadable cartridge including a suture holding region (capsule).

FIGS. 13A-13G illustrate the operation of a preloaded and automaticallyreloadable apparatus, passing a first bight of suture, thenautomatically reloading the tissue penetrator for passing a second bightof suture by automatically applying tension between a second bight thatis not on the tissue penetrator and an adjacent end region of the suturethat is releasably held by the tissue penetrator.

FIGS. 14A and 14B illustrate connecting a preloaded and automaticallyreloadable cartridge with a suture passer assembly.

FIGS. 15A-15E show another example of a method of connecting a reloadedand automatically reloadable cartridge to a suture passer assembly.

FIG. 16A shows a bottom perspective view of the underside of a suturepasser assembly to which a reloaded and automatically reloadablecartridge may be coupled.

FIG. 16B shows an enlarged view of a keyed coupling region of the suturepasser assembly shown in FIG. 16A.

FIG. 16C shows an enlarged view of another region of the underside of asuture passer assembly to which a reloaded and automatically reloadablecartridge may be coupled including a retainer element for retaining andreleasing the cartridge.

FIG. 17A illustrates another variation of coupling a reloaded andautomatically reloadable cartridge to a suture passer assembly. FIG. 17Bis an enlarged view of coupling region between the reloaded andautomatically reloadable cartridge and the durable/reusable suturepasser assembly.

FIGS. 18A-18E illustrate a method of loading a suture passer with twoloops of suture that may be sequentially passed by the suture passer,indicating a pre-loaded (though not necessary automatically reloading)suture passer.

FIGS. 19A and 19B schematically illustrate two variations of suturepassers in which both legs of a loop of suture are held on the same sideof the jaw of the suture passer.

FIG. 20 shows another variation of a suture passer configured tosequentially pass two lengths of suture.

FIG. 21 shows another variation of a suture passer configured to passtwo lengths of suture.

FIG. 22A shows a top view of one variation of a jaw member in which toloops (bights) of suture have been loaded.

FIG. 22B shows a top views of the jaw member of FIG. 22A in which thesecond suture bight is held taught by a suture management element.

In FIG. 22C the suture bight has been automatically loaded into thesuture retainer region of a tissue penetrator.

FIG. 22D shows the same view of the jaw member after the suturemanagement element has released the suture bight.

FIGS. 22E-22H illustrate the use of a suture management feature tosecure and apply tension to one of the loops of suture loaded into thejaw member of FIG. 22A during loading and operation of a suture passer.

FIG. 23 shows a bottom perspective view of one variation of a suturepasser device including a suture cleat holding a suture.

FIGS. 24A and 24B illustrate one variation of a suture managementfeature (e.g., cleat) configured to automatically release one or morelengths of suture during operation of a suture passer.

FIGS. 25A and 25B illustrate another variation of a suture cleat.

FIGS. 26A-26L illustrate one method (including optional steps) ofoperating a system such as the systems described herein including apreloaded and automatically reloadable cartridge to repair tissue. InFIGS. 26A-26L, the tissue being repaired corresponds to knee meniscustissue.

FIGS. 27A-27C show variations of jaws (e.g., second jaws) of a suturepasser. The variation shown in FIG. 27A includes a deflection region fordeflecting a tissue penetrator at the widest point of the jaw profile.

FIG. 27D shows the variation of FIG. 27A with the tissue penetratorextended. FIG. 27E shows the variation of FIG. 27B with the tissuepenetrator extended. FIG. 27F shows the variation of FIG. 27C with thetissue penetrator extended.

FIGS. 28A-28H illustrate use of a suture passer described herein to forma loop around a target tissue.

FIGS. 29A-29D illustrate one variation of a suture passer as describedherein, adapted to pass a suture through the tissue twice without havingto re-load.

FIGS. 30A-30I illustrate a variation of a suture passer describe herein,adapted to pass a suture through the tissue twice without having tore-load.

FIGS. 31A-31D illustrate operation of a suture passer as described inFIGS. 30A-30I.

FIGS. 32A-32D illustrate another variation of a suture passer deviceincluding suture snaring (grasping) and release feature for passing asuture through a tissue to form a loop around the target tissue.

FIGS. 33A-33D illustrate operation of a suture passer as shown in FIGS.32A-32D.

FIGS. 34A-34G illustrates a suture passer device and suture captureelement passing a suture twice through a target tissue to form a loop ofsuture around the target tissue.

FIGS. 35A and 35B illustrate variations of suture capture elements asdescribed herein.

FIGS. 36A-36I show operation and aspects of a suture passer using anexpandable capture element.

FIGS. 37A and 37B show alternative suture capture elements engaging atissue penetrator.

FIGS. 38A and 38B illustrate clamping of tissue (e.g., meniscus tissue)between the jaws of a suture passer.

FIGS. 39A and 39B illustrate the contact points of a suture passer withand without conjugate motion when clamping tissue between the jaws ofthe suture passer.

FIG. 40 illustrates a mechanism for achieving conjugate motion betweenan axial moveable lower jaw and a hinged/pivoting upper jaw.

FIG. 41 illustrates operation of a suture passer device including avisual marking/notification element that projects light though thetissue to indicate the path that the needle (tissue penetrator) willtake.

FIGS. 42A-42C illustrate a suture passer device having anaudible/tactile feedback indicating the extension of the tissuepenetrator.

FIG. 43A shows a section through a “thin” variation of a suture passer.

FIGS. 43B-43D illustrate enlarged views of various region of the suturepasser of FIG. 43A.

FIG. 44 shows the distal end region of the suture passer of FIG. 43A.

FIGS. 45A and 45B show portions of the suture passer of FIG. 43A adaptedto reduce the height of the device.

FIGS. 46A and 46B show examples of suture passers having full elongatebody housing (FIG. 46A) and a partial or c-shaped elongate body housing(FIG. 46B) from a top perspective view.

FIGS. 47A and 47B show bottom perspective views of the same suturepassers of FIGS. 46A and 46B, respectively.

FIG. 48A shows an upper jaw having a radiused (curved) outer surfacenear the proximal region and a uniform thickness along much of thelength.

FIG. 48B shows an upper jaw having a straight (un-curved) proximalregion and a uniform thickness along much of the length.

FIG. 48C shows an overlaid view of the upper jaws of FIGS. 48A and 48B,showing the differences in curvature near the proximal end regions.

FIG. 48D shows a hybrid upper jaw having a curved (radiused) uppersurface and a straight lower, tissue-contacting, surface. The hybridupper jaw is thinner in width proximally than distally.

FIG. 49A shows a top view of a lower jaw member having a tissuepenetrator with a laterally positioned sharp tip (relative to the widthof the tissue penetrator).

FIG. 49B shows an example of a needle tip that is miss-directed lateralto the upper jaw when extending through the tissue because of the normalforce exerted against the angled, asymmetric tip as it passes throughthe tissue.

FIG. 49C shows an example of a lower jaw including a tissue penetratorhaving a distal tip region that is less than 40% off-center. The lowerjaw member includes a tip shield region in the central suture loadingchannel to prevent a suture from snagging on the sharp distal tip whenloading/unloading into the tissue penetrator.

FIG. 50A is a schematic view of the distal end or a tissue penetratorhaving side-opening suture retainer region.

FIG. 50B is a picture of a tissue penetrator such as the one shown inFIG. 50A with the proximal portion of the side-opening into the sutureretainer region caught on tissue as the tissue penetrator extends out ofthe tissue.

FIG. 50C shows a tissue penetrator having a modified proximal portion ofthe side opening configured to prevent snagging of the side-opening onthe tissue.

FIG. 50D shows an enlarged view of the ramp region of the tissuepenetrator shown in FIG. 50C.

FIG. 51A shows a side perspective view of an example of a pre-loaded andautomatically re-loading cartridge that includes a pre-tied knot.

FIG. 51B shows one example of a side sectional view through a pre-loadedcartridge similar to the variation shown in FIG. 51A.

FIG. 51C illustrates one variation of a pre-tied suture knot system thatmay be loaded into a cartridge such as the one shown in FIG. 51A.

FIG. 52 illustrates insertion of a suture passer including a pre-loadedcartridge that has a suture with a pre-tied knot pre-loaded into thecartridge into a subject's knee (e.g., for meniscus repair).

FIGS. 53A-53C illustrate one method of operating a suture passerincluding a pre-loaded and automatically re-loading cartridge holding apre-tied knot to pass suture through a tissue (e.g., a torn meniscus).

FIGS. 54A-54C illustrate removal of the suture passer shown in FIGS.53A-53C and tightening of the pre-tied knot to secure the suture tissue.

FIGS. 55A-55E show internal views of the tissue being sutured, using amethod similar to that shown in FIGS. 53A-54C.

DETAILED DESCRIPTION

In general, described herein are sutures passers, methods of operatingthem, and methods of repairing tissue using them. These suture passersmay be used arthroscopically, and may be used to pass one or more lengthof suture. These suture passers may include an elongate body and a firstjaw member (e.g., first jaw) extending from the distal end of theelongate body, wherein the first jaw is bent or bendable relative to thedistal to proximal axis of the elongate body. In some variations thefirst jaw is hinged near the distal end region of the elongate body.Some variations of the suture passers described herein include a secondjaw member (e.g., second jaw) that is configured to slide axially(proximally and distally) relative to the elongate body and/or firstjaw. The second jaw may be configured to slide axially sufficiently farproximally so that the distal tip of the second jaw is proximal to thedistal end of the shaft (e.g., completely retracted). The first andsecond jaws may be configured to form a distal-facing opening into whichtissue may be held. The suture passers described herein may also includea flexible, bendable, or pre-bent tissue penetrator for passing a suturethrough the tissue. The suture passer may also include a handle at theproximal end with one or more controls for actuating the first and/orsecond jaws and the tissue penetrator.

The suture passer described herein may have very narrow (thin) jaws. Thetissue penetrator may exit the second jaw from the side of the secondjaw and extend across a distal-facing opening to engage an opening inthe opposite jaw (e.g., the first jaw), where a suture may be securedand/or released. For example, the suture passers described herein mayhave a second jaw having a maximum diameter (e.g., maximum height) alongthe length of the second jaw of less than about 0.11 inches, 0.10inches, 0.09 inches, 0.08 inches, 0.07 inches, 0.06 inches, 0.05 inches,0.04 inches, 0.03 inches, 0.2 inches, 0.01 inches, etc. The second jawmay be any appropriate width. For example, the width may beapproximately 0.15 inches.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Pre-Loaded Suture Passers

Described herein are suture passers and cartridges for suture passersthat are preloaded with one, or more preferably, more than one, lengthof suture that can be passed through tissue by the suture passer withoutrequiring manual loading. In particular, the preloaded suture passersand cartridges for suture passers include a suture holding/tensioningmechanism, which may be referred to as a releasable hold that isconnected to, and may ride on, the tissue penetrator (“needle”); thereleasable hold releasably secures an end of the suture and providessufficient tension to load the suture onto the tissue penetrator duringoperation. A tissue penetrator may also and alternatively be referred toas a needle. A tissue penetrator/needle is generally configured topierce tissue and pass (push and/or pull) suture. A tissue penetratormay be flat, cylindrical, etc. and may have a square, oval, circular, orother shaped cross-section. The tissue penetrator is generally elongatedand may include a notch, eye, hook, or the like for engaging a suturenear or at its distal end.

In general, a suture passer device as described herein may be referredto as suture passer and/or a suturing device. Any of the featuresdescribed herein may be included as part of a low-profile suture passerthat includes a pair of jaws (e.g., distal-facing jaws) between whichthe needle may extend to pass suture. The low-profile suture passers maybe configured to allow axial (sliding) movement of a jaw of the suturepasser relative to the elongate body of the suture passer; the suturepasser may also be configured so that the opposite jaw of the suturepasser pivots or rotates relative to the elongate body of the suturepasser, so that tissue can be clamped between the jaws before and/orduring suturing. Low-profile suture passers having both sliding androtating jaws may be referred to as dual deployment suture passers,and/or clamping/sliding suture passers.

For example, a suture passer may generally include a first jaw memberand second jaw member that both extend from the end of an elongate bodyregion to form a distal-facing mouth into which tissue to be suturedfits. One or both jaws forming the mouth may be independently moved.FIGS. 1A and 1B illustrate one variation of a dual deployment suturepasser 100. In this example, the device has a first (upper) jaw member103 extending distally from the distal end of a more proximal elongatemember 101. A second jaw member 105 (in FIG. 1B) extends distallybeneath the first jaw member 103. This second jaw member may slidedistally and proximally to retract and extend. A handle 107 is locatedat the proximal end of the device and includes multiple controls forindependently controlling the movements of the first jaw 103, second jaw105, and tissue penetrator (not shown in FIGS. 1A and 1B, though it maybe housed with the tip retracted within either the first or second jaws.

One example of a suture passer that may be configured as a preloadedsuture passer is shown in FIGS. 1A and 1B. In FIG. 1A, a first jawmember 103 is held at an angle relative to a long axis of the proximalelongate member 101. The first jaw 103 in this example is curved(“radiused”) slightly and connected to the elongate body by a hingeregion 113 about which the first jaw 103 may be angled relative to theelongate member 101. In some variations, this hinge region is a pinnedhinge; non-pinned (e.g., living hinges) regions may be used. Anyappropriate articulating region that allows the first jaw member to moveat an angle relative to the proximal portion of the device (e.g., theelongate member) may be used. In some variations, this first jaw member103 is referred to as an upper jaw member, but alternative variations(in which the first jaw member is a lower jaw member) are also possible.

A jaw lever 181 can be used to move (bend) or hold the first jaw member103 angle. The first jaw member 103 may be actuated by any appropriatemechanism, including a tendon member (e.g., push rod, pull rod, or thelike), and may be held (locked) at any angle (e.g., between 0° and 180°relative to a line extending from the distal end of the elongate body,between about 0° and 90°, between about 0° and 60°, etc.). In somevariations the device has a neutral position during which no force isapplied to the controller to move the first jaw member, so that thefirst jaw member is angled “open” (e.g., at 30°, 45°, 50°, 90° or at anyangle between about 15° and about 90°) relative to the elongate body;actuating (e.g., pressing) the control on the handle results in thefirst jaw member moving towards the “closed” position (e.g., reducingthe angle with respect to a line extending from the distal end of theelongate body). In some variations the jaw member is in the neutralposition when angled with 0°/180° relative to the elongate body.

The first jaw member 103 shown in FIGS. 1A and 1B also includes a sutureretainer region near the distal end. A suture retainer can hold a suturethat has been passed into the suture retainer from the tissuepenetrator. This suture retainer region may include a grasper, a pair ofgraspers, a deflectable member into which the suture may be pushed andheld (e.g., handed off from the tissue penetrator), or the like. Forexample, the retainer may be a leaf spring element that is displaced bythe tissue penetrator as it enters the jaw member in variation in whichthe tissue penetrator is housed in/behind the lower (sliding) jaw.

The second jaw 105 is shown in FIG. 1B as a lower jaw member. In thisvariation, the lower jaw 105 is configured to slide proximally towardsand into the proximal elongate body 101 of the device (as shown in FIG.1A). The second jaw 105 typically moves axially, in the direction of theproximal-distal axis of the suture passer. The second jaw member 105 maymove axially completely past the distal end of the elongate body;alternatively, the second jaw member 105 may slide axially in theproximal direction only partially (e.g. to align with the hinge regionof the first jaw member). The suture passer may be configured so thatthe second jaw 105 can retract completely into, and extend out of, thelower portion of the elongate body 101. A control (e.g., retractorlever) 171 on the handle 107 can be used to trigger retraction of thesecond jaw member 105 while another control (e.g., lower jaw/needlelever) 191 can be used to extend the second jaw 105. In FIGS. 1A and 1B,the lower jaw/needle lever is configured to both extend the lower jawwhen squeezed once, and to extend and retract the tissue penetrator(needle) when squeezing the lever a second time; squeezing the secondtime extends the needle and releasing the lever retracts the needle.

A tissue penetrator (not visible in FIGS. 1A and 1B) may be housedwithin or behind the second jaw 105. Alternatively, the suture passermay be configured so that the tissue penetrator is housed within orbehind the upper jaw and the suture retainer region is on the opposite(e.g., lower) jaw. The tissue penetrator may be configured as a needle,wire, knife, blade, or other element that is configured to extend fromwithin either the first or second jaw members and across the openingbetween the jaw members to engage a suture and push the suture throughthe tissue from a first jaw (e.g., the lower jaw) where it can be heldby the suture retainer region on the opposite jaw (e.g., the upper jaw).In general, the tissue penetrator may be configured to completelyretract into the housing of the second jaw member 105. It may beextended across the opening between the jaws by actuating a member inthe handle to push or otherwise drive (slide) it out of the jaw anddeflect it across the opening, and though any tissue held between thejaws. In FIGS. 1A and 1B, the second jaw member 105 completely housesthe tissue penetrator and includes a deflection region that drives thetissue penetrator up and out of the second jaw member by deflecting itacross the opening between the two. The jaw/needle lever 191 can be usedto extend the tissue penetrator (for example, a first squeeze canadvance the second jaw member 105 and once the lower jaw is extended, anadditional squeeze or squeezes can extend the needle.

A suture passer, such as the suture passer described in FIGS. 1A and 1B,can be configured to be preloaded with suture for multiple passes. Thiscan be performed either with a replaceable cartridge or by configuringthe lower jaw of the suture passer to include a suture having a firstbight (e.g., bend, loop, etc.) region, a second bight region, a tissuepenetrator holding the first length (bight) of suture, a suture holdingregion holding the second bight, and a releasable hold on the suturepasser that drives the second bight region from the holding region tore-load the tissue penetrator after the first bight has been passed.

For example, a suture passer apparatus as described herein may beconfigured to operate with cartridge (e.g., a preloaded cartridge). Ingeneral, the preloaded cartridge may be part of a replaceable assemblythat is preloaded with suture; the preloaded cartridge engages with adurable assembly including components of the suture passer that can bere-used, while the cartridge includes “disposable” components (e.g.,suture, tissue penetrator) that are consumable, and/or limited-use.

In general, a cartridge may include one of the jaw members of a suturepasser, such as the lower jaw, the suture, and the tissue penetrator, aswell as a releasable hold that re-loads the suture into the tissuepenetrator after it has been passed. A cartridge may also include ahousing that completely or partially covers the suture and tissuepenetrator. The housing may also include a storage region (e.g.,capsule) for holding the length(s) of suture, and any additional suturemanagement components (e.g., funnels, channels, spools, etc.) forguiding the suture. As mentioned above, in some variations a removable,replaceable and/or releasable cartridge is not used, but the entiresuture passer may be preloaded with suture and disposable after use.

In some variations of the cartridge described herein the cartridge ispreloaded with suture and a tissue penetrator and engages with a durablesuture passer body. The reusable or durable suture passer body may bereferred to as a durable portion or durable assembly of a suture passerapparatus. In general, the durable portion may include an elongate body,a first jaw member (e.g., pivoting, bent, bendable, or fixed), and ahandle including controls for controlling movement of the jaw(s) andtissue penetrator. The replaceable cartridge portion may be referred toas a cartridge assembly, and typically includes a housing attached to orforming all or part of a (e.g., second) jaw, a tissue penetrator (e.g.,needle) and a suture. The suture is typically both preloaded into thetissue penetrator and may also be “primed” for loading a second lengthinto the tissue penetrator after the first length has been passed fromthe tissue penetrator.

For example, the second jaw member 105 can be part of a suture cartridgethat is configured to hold at least two preloaded loops of suture to bepassed. Further, as described more detail below, the suture cartridgecan be configured to attach to and detach from the rest of the apparatus(e.g., to the durable assembly portion of the suture passer).

FIGS. 1C and 1D illustrate a suture passer 200 that is configured as aclamping/sliding suture passer, having both a sliding lower jaw 205 andbending/pivoting upper jaw 207, where the lower jaw is formed as part ofa preloaded cartridge 203. In FIG. 1C the durable assembly 201 and thereplaceable cartridge assembly 203 are combined to form the suturepasser 200. The suture passer. When combined, the operation of thedevice may be controlled as described above. The handle 209 includes afirst control (upper jaw or bending jaw control) 211 for controlling theangle of the upper jaw 202, a second control (e.g., jaw extending/needleextending control) 213 for controlling extension of the lower jaw andextension/retraction of the tissue penetrator, and a lower jaw release215 control that retracts the lower jaw after it has been extended. InFIGS. 1C and 1D, the lower jaw is part of the cartridge assembly and inFIG. 1C is shown retracted proximally relative to the elongate shaft 220of the apparatus. In FIG. 1D, the lower jaw 205 is shown extendeddistally relative to the long axis (e.g., the distal-to-proximal axis ofthe elongate body 220); this may be achieved by actuating (e.g.,squeezing) the second control to extend the entire cartridge 203 andtherefore the lower jaw region 205 distally. When extended distally theupper 202 and lower 205 jaws form a distal-facing opening across which atissue penetrator (not shown) may be extended from the cartridge to passthe preloaded suture.

FIG. 3A illustrates one embodiment of a durable assembly 300 of a suturepasser, without the attached cartridge shown in FIG. 3B. In FIG. 3A, thedurable assembly includes the upper jaw 302, an elongate body 320, and ahandle 330 with controls. The durable assembly is adapted for releasablycoupling with a preloaded cartridge, such as the one shown in FIG. 3B.For example the durable assembly may include one or more keyed regionsto which a cartridge may be coupled. The cartridge may therefore includecomplementary regions for engaging the durable assembly. An example ofhow a cartridge may be engaged with a durable assembly to form thesuture passer is described in greater detail below.

FIGS. 3B and 3C show perspective views of a cartridge 301 that includesa jaw (lower jaw) region 305 and a housing 309 that at least partiallyencloses a suture, tissue penetrator, suture holding region andreleasable hold on the tissue penetrator. In this example, the housingincludes a lower jaw region 305, an elongate region 319, and a suturecapsule 321. The suture capsule stores at least a portion of the sutureto be passed. In some variations a single long (e.g., 2 inches, 3inches, 4 inches, 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10inches, 12 inches, 13 inches, 14 inches, etc.) length of suture may beused to form both a first bight region and a second bight region thatare separately passed by the device and loaded automatically and/orpreloaded into the tissue penetrator by the cartridge. The first bightmay be at one end region and the second bight may be at the other endregion. As indicated in FIG. 3C, the cartridge 301 may be connected anddisconnected from the durable assembly 300. Thus, in operation a newpreloaded cartridge 301 may be connected to a durable assembly 300, thedevice may be used (e.g., to pass two lengths/bights of suture) and theassembly may be removed and a fresh (preloaded) cartridge attached. Theused cartridge may be refurbished (e.g., by replacing the suture and/orthe tissue penetrator), reloaded, recycled, or otherwise disposed of. Aportion of the cartridge may be inserted into the durable assembly. Forexample, in FIG. 3C, the suture capsule region 321 may be retracted intoa portion 325 of the handle when the lower jaw is retracted proximally.

The elongate body 101 shown in FIGS. 1A-3C is illustrated as arelatively straight, flattened and cylindrical structure, though othershapes may be used. For example, the elongate body may be curved, bent,or angled. In some variations the elongate body is configured to bebent, curved or angled dynamically (e.g. by changing the bend or curve).

The elongate body of the suture passer (which may include both theelongate body region of the durable component and/or the elongate bodyportion of the cartridge that can mate with the durable component) maybe any appropriate length. For example, the elongate body may be betweenabout 6 and about 24 inches long, e.g., 6 inches long, 8 inches long, 10inches long, 12 inches long, etc. The suture passers described hereinmay be used for arthroscopic surgeries and therefore may be dimensionedfor use as such. Thus the diameter of the device may be configured to besmall enough for insertion into a cannula, tube or the like forinsertion into the body.

In general, a suture can be preloaded in a suture cartridge 1000 for usein automatically and sequentially passing two or more lengths of suturewith a suture passer, such as the suture passers of FIG. 1A-1B or 1C-1D.FIG. 4A illustrate a variation of a suture cartridge 400 configured tobe used as part of a suture passer that can hold and pass two lengths ofsuture. As mentioned, the suture cartridge 400 can be configured toattach and detach from a durable assembly of a suture passer. The suturecartridge 400 in this example includes a lower jaw 405 (i.e. similar tothe lower jaw 105 of FIGS. 1A and 1B) as well as a suture storagecapsule 421.

The lower jaw 405 can include a housing 409 that encloses a tissuepenetrator 403 and first and second bights. A track can run within thehousing 409 of the cartridge along which the tissue penetrator 403 canslide when moving within and/or extending in and out of the cartridge.The track can be sized such that the tissue penetrator 403 fits withinthe track but prevents the suture from engaging in the track. A sutureholding region (not visible in FIG. 4A) may be formed between thehousing (e.g., the track) and the tissue penetrator, for holding thesecond bight region of suture. A top cover 407 can be placed over adistal portion of the housing which may help retain the ends of thesuture(s), including the bight regions, in a correct position within thecartridge.

FIG. 4B shows an exploded view of the cartridge shown in FIG. 4A. Thecartridge may be assembled to include the housing 409, which may bereferred to as a jaw housing or lower jaw housing. A suture holdingregion (suture capsule 421) may be integral with the jaw housing orseparate from it, but is attached so that the suture can continue fromthe jaw housing to the suture holding region. If the holding region 421is separate from the jaw housing 409, a connection tab 419 may beattached over the housing at the proximal end of the cartridge and maysecure the holding region to the rest of the housing. The inner region410 of the housing may be configured to hold the suture and tissuepenetrator, and also to allow the tissue penetrator to slide within andout of the housing. For example, the inner region 410 of the housing mayinclude a distal deflector (ramp) region 433. The housing 409 may alsoinclude the engagement regions such as extending structures (posts,flanges, etc.) that may be keyed to complementary engagement regions ona durable assembly to secure the durable assembly and the cartridgetogether. In FIG. 4B, two sets of flanges or keyed regions 444, 446 areshown.

A suture 460 and tissue penetrator 403 may also fit within thecartridges lower jaw housing. In FIG. 4B, the suture is shown coupled tothe tissue penetrator so that a first bight is preloaded into a notchregion forming a suture engagement region of the tissue penetrator. Asecond bight at the second end of the same suture is held to the side ofthe tissue penetrator and the end region of the suture distal from thesecond bight region is coupled to the tissue penetrator by a releasablehold 470 configured as a clasp in this example. The tissue penetratormay be coupled to a sled (e.g., needle sled) 475 that is also heldwithin the jaw housing. As described in detail below in some variationsa separate releasable hold is not required; for example the sled may beconfigured to include the releasable hold (see, e.g., FIG. 11A). Aneedle sled may act to couple the tissue penetrator to a push/pull rodin the durable component for actuating the needle. The lower jaw housingmay also include a cover (e.g., top cover) 407 over all or a portion ofthe jaw housing, such as the distal end region. Additional suturemanagement regions may also be included, such as a funnel 417 that canbe used to guide the suture within the housing, and help prevent it fromtangling within the housing or getting pinched between a wall of thehousing and the needle.

FIGS. 5A-5C show additional detail of a variation of an assembledcartridge such as the one shown in FIG. 4A. In FIG. 5A, a top view ofthe distal end region of the assembly shows a housing 509, top cover507, and tissue penetrator 503. A releasable hold 570 is coupled to thetissue penetrator, holding a distal end region of a suture 560. Thehousing includes a flanged region 544 to engage with a durable assemblyof a suture passer, and a ramped deflection region 533 to direct thetissue penetrator laterally from the cartridge.

FIG. 5B shows a side perspective view and FIG. 5C shows a side view. Ascan be seen in FIG. 5B, the cartridge, and particularly the lower jawregion 505 is thin and relatively flat. FIG. 6 is an enlarged andexploded view of the distal end of the cartridge, showing the housing509, a suture 560 (including a first bight region 561 and second bightregion 563), tissue penetrator 503 (including suture engagement region513), a releasable hold (clasp 570), top cover 507, and suturemanagement element (funnel 517).

Similarly, FIGS. 7A and 7B show a top view of the distal end region of acartridge. In FIG. 7A a top cover has been made removed to show how thebights and end regions of the suture engage with the tissue penetratorwithin the cartridge. As shown in FIG. 7A, the first bight 761 of sutureis held in the suture engagement region 713 of the tissue penetrator. Atissue penetrator generally retains a suture so that the suture can bepushed (or, in some variations pulled, or pushed and pulled) through thetissue by the tissue penetrator until it is held by a suture retainer onthe opposite jaw. For example, in FIG. 7A, the tissue penetratorincludes a notched region forming the suture engagement region 713; thenotch is oriented at an angle relative to the length of the tissuepenetrator, directed proximally, so that the suture is retained withinthe tissue penetrator as it is advanced distally. Other sutureengagement regions may be used, including distal-facing sutureengagement regions, or the like.

In FIG. 7A, a single suture forms the first and second bight regions;the portion of the suture between the first bight 761 and the secondbight 763 runs behind the tissue penetrator (not visible in FIG. 7A),between the tissue penetrator and the jaw housing 709. The second bightregion 763 on the opposite end of the suture is held in a suture holdingregion 722 that is off of the tissue penetrator, while the distal endregion of the suture just distal to the second bight region 763 issecured to the tissue penetrator by the releasable hold (not visible inFIG. 7A, but see, e.g., FIG. 5A). The suture holding region 722 in FIGS.7A and 7B is a notched region formed within the jaw housing laterallypositioned relative to the tissue penetrator, and on the same side ofthe tissue penetrator as the opening into the suture engagement region713 of the tissue penetrator 703. In operation, the suture holdingregion holds the second bight until the suture engagement region of thetissue penetrator is empty (e.g., of a bight of suture).

As used herein, a bight or bight region of suture refers to a length ofsuture. The length of suture forming the bight may be bent or looped;for example, the bight region may be bent so that the suture bends 180degrees, as illustrate din FIG. 7A and FIG. 7C, discussed below. In somevariations the bend forming the bight may prevent the suture fromsliding or pulling distally or proximally.

Returning now to FIG. 8 , a tissue penetrator may include any needle. InFIGS. 5A-7A and FIG. 8 , the needle is a flat, elongated length of shapememory alloy (e.g. Nitinol) that is superelastic; however, othermaterials and shapes may be used. For example, a needle may becylindrical, have a round or oval cross-section, etc. Although it may bebeneficial to use a superelastic material such as a shape memory alloy,because the cartridge may be configured to deflect the needle a smallnumber of times, the needle may be formed of other plastics and/ormetals capable of passing through the tissue (e.g., having sufficientcolumn strength to be pushed through the tissue).

In FIG. 8 , the suture is shown on the tissue penetrator 803, so the endof the suture 864 near the first bight 861 extends on the same side ofthe tissue penetrator 803 as the distal end region 865 of the secondbight 862. The distal end region 865 of the suture closest to the secondbight region 863 is held against the tissue penetrator (fixed to thetissue penetrator) by the releasable hold 870, which is positionedproximally down the length of the tissue penetrator from the sutureengagement region and the first and second bights.

As will be described in greater detail below, the releasable hold actsto secure an end region of the suture to the tissue penetrator in apredetermined position. The releasable hold is releasable because it isconfigured to release the end region of the suture from the tissuepenetrator when a pull force on the suture is greater than a thresholdrelease force. When the pull force on the suture exceeds the releaseforce, the suture may be drawn out of the releasable hold; until thatpoint, the releasable hold prevents the suture end region from beingreleased.

Any appropriate releasable hold may be used. The release hold may be amechanical hold (e.g., clamp, an O-ring, a clip, a clasp, a frictionreleasable hold, a band, a crimp, etc.), a frangible hold (e.g., a waxhold, releasable adhesive, etc.), or the like. For example, FIGS. 9A-9Dillustrate one variation of a releasable hold configured as a clasp thatis secured to a predetermined portion of the tissue penetrator. FIG. 9Ashows a side perspective view of the releasable hold. The hold includesa channel that fits over a cut-out region of the tissue penetrator 903,as shown in FIGS. 9C and 9D in top and bottom perspective views,respectively. An example of the cut-out region 910 into which areleasable hold such as the one shown in FIG. 9A-9D may fit is shown inFIG. 6 . The cut-out region may prevent the releasable hold from slidingor migrating on the tissue penetrator during operation. In somevariations the releasable hold may be affixed (e.g., glued, welded,etc.) to the tissue penetrator.

In some variations, such as the releasable hold shown in FIGS. 10A-10D,the releasable hold does not engage a cut-out region, but may secure toa tissue penetrator even where a notched or cut-out region is notincluded. For example the releasable hold may be allowed to slide ifforces acting on the releasable hold exceed a threshold level(releasable hold sliding threshold). In FIG. 10A, the releasable hold isconfigured as a clamp 1001 that may secured over the tissue penetrator1013 and lock down onto the tissue penetrator.

FIGS. 10C and 10D also illustrate the releasable hold engaging andsecuring a distal end region of a suture 1005. On the opposite side ofthe tissue penetrator, the elongate portion of the suture between thefirst and second bights 1088, 1088′ extends under the tissue penetratorand past the releasable hold without being retained by the releasablehold.

In some variations the releasable hold is formed as part of anotherportion of the apparatus that is attached and moves with the tissuepenetrator, such as a coupler coupling the tissue penetrator to anactuator. Thus a separate releasable hold is not necessary. In somevariations the releasable hold comprises a sled (needle sled) that isadapted to releasable hold an end region of suture to the tissuepenetrator. For example, FIGS. 11A-11D illustrate a variation in whichthe releasable hold is configured as a sled that also couples the tissuepenetrator to an actuator, for example, when the cartridge is coupledwith a durable suture passer.

FIG. 11A shows a top view of a cartridge (or lower jaw assembly) inwhich the releasable hold is formed by the sled 1188. In FIG. 11A, thereleasable hold comprises a region 1189 at the distal end of the sledhaving two clasp portions that form a narrow gap through which the endregion of the suture 1195 passes. The suture end 1195 is pinches betweenthe tissue penetrator 1199 and a first releasable hold region 1189 a anda second releasable hold region 1189 b. Thus, a separate releasable holdelement is not needed.

FIG. 11B the sled 1188 is shown removed from the lower jaw assembly. Thesled includes an internal track region into which the tissue penetratormay be inserted. The distal end of the sled, as shown in greater detailin FIG. 11C, is adapted to form a releasable hold. The releasable holdcompresses the end region of the suture 1095 between a first surface onthe sled and the upper surface of a tissue penetrator held within thesled. In some variations the tissue penetrator is deflected slightly bythe sled so that it curves/bends upwards slightly at this releasablehold region to hold the suture within releasable hold. In FIGS. 11A-11Cthe releasable hold region of the sled forms two retaining surfaces 1189a and 1189 b in the sled so that there are two contact points retainingthe suture, pinching the suture end between the tissue penetrator (whichis coupled to the sled) and the distal end of the sled. In somevariations the sled includes a single contact region forming thereleasable hold. FIG. 11D shows an alternative exploded view of acartridge in which the releasable hold is configured as a distal portionof the needle sled. The cartridge includes a housing 1109, which may bereferred to as a jaw housing or lower jaw housing. A suture holdingregion (suture capsule 1121) may be integral with the jaw housing orseparate from it, but is attached so that the suture can continue fromthe jaw housing to the suture holding region. If the capsule 1121 isseparate from the jaw housing 1109, a connection tab 1119 may beattached over the housing at the proximal end of the cartridge and maysecure the holding region to the rest of the housing. The inner regionof the housing 1109 may be configured to hold the suture 1103 and tissuepenetrator 1105, and also to allow the tissue penetrator to slide withinand out of the housing. The inner region of the housing may include adistal deflector (ramp) region 1133. The housing 1109 may also includethe engagement regions such as extending structures (posts, flanges1155, etc.) that may be keyed to complementary engagement regions on adurable suture passer assembly to secure the durable suture passerassembly and the cartridge together. A top cover 1165 and funnel (sutureguide) 1166 may also be included. In FIG. 11D, the sled 1188 includesthe releasable hold (region 1189), as discussed above.

Returning now to FIG. 7C, FIG. 7C illustrates the relationship betweenthe distal end of a tissue penetrator 1001 and a suture. In thisexample, as discussed above, the first and second bight regions 1031 a,1031 b are be opposite ends of a single long suture strand 1031. Asmentioned, in some variations more than one suture may be used (e.g., afirst suture forming the first bight, a second suture forming the secondbight, etc.). In FIG. 7C, the first bight region 1031 a (i.e. the loopthat will be passed first during use) extends through, and is held inplace by, the notch 1067 forming the suture engagement region in thetissue penetrator 1001. The second bight region 1031 b (i.e., the loopthat will be passed second during use) is held in a suture holdingregion (not visible in FIG. 7C). The end of the suture closest to thesecond bight is secured to the tissue penetrator 1001 by a releasablehold 1055 (show configured as a clasp). The first bight region 1031 a ofthe suture 1031, when preloaded, can thus wind such that the end of thesuture nearest the first bight is located between the top cover 1047 andthe tissue penetrator 1001. The body of the loop (bight 1031 a) extendsthrough the notch 1067 to the bottom of the housing 1023, runs betweenthe tissue penetrator 1001 and the bottom of the jaw housing 1023, andthe intermediate portion of the suture between the first bight 1031 aand the second bight 1301 b extends along the length of the jaw memberand into a suture storage region of the housing (e.g., suture capsulenot visible in FIG. 7C). In FIG. 7C, this intermediate portion is notshown to scale, it may be longer than indicated. For example, theintermediate portion may be 2 inches, 3 inches, 4 inches, 5 inches, 6inches, 7 inches, 8 inches, 9 inches, 10 inches, 12 inches, 13 inches,14 inches, etc. The intermediate portion of suture may be loosely held,so that it may be withdrawn out of the housing relatively easily afterpassing the first and/or second bight. FIGS. 12A-12C illustrateperspective, top and side views, respectively, of a suture storageregion (suture capsule) that may be located at the proximal end of acartridge, which may hold some of this intermediate portion of thesuture(s). The body of the suture 1031 can then be wound or otherwisestored. The second bight region 1031 b extends from the suture storageregion, runs between the tissue penetrator 1001 and the bottom of thehousing 1023, and extend into a suture holding region (e.g., notch)formed in the housing between the housing 1023 and the tissue penetrator1001. The end of the suture distal to the second bight then extendsbetween the top cover 1047 and the tissue penetrator 1001 and is heldtight by the releasable hold (clasp 1055). For convenience, the suturemay be considered to run from proximal (near the first bight) to distal(near the second bight).

As mentioned above, the releasable hold can attach to the tissuepenetrator 1001 and apply tension to the second bight 1031 b. Forexample, the releasable hold may be a suture clasp 1055 that pins thesuture to the tissue penetrator. The releasable hold 1055 is typicallyconfigured to travel with the tissue penetrator 1001 as the penetrator1001 moves axially. As the tissue penetrator slides distally andproximally, the second bight region of the suture remains inapproximately the same location (relative to the jaw housing of thecartridge), while the end of the suture connected to the second bightand pinned to the tissue penetrator by the releasable hold movesdistally and proximally with the tissue penetrator. When the secondbight region is held in the suture holding region in the jaw housing, asthe tissue penetrator extends distally (as when passing a bight regionof suture between the jaws), the tension on the end of the suturebetween the second bight region and the releasable hold is decreased(producing a “slack” region); when the tissue penetrator is extendedproximally (as when retracting the tissue penetrator into the jawhousing), the tension on the second bight region and the region ofsuture between the second bight region and the releasable hold isincreased. This increased tension on the second bight tends to draw thesecond bight proximally; if the tissue penetrator is withdrawnproximally to a position where the suture engagement region of thetissue penetrator is aligned with the suture holding region, and thesuture engagement region is empty, the suture will be drawn into thesuture engagement region. If the suture engagement region is occupied(e.g., by another suture bight), the second suture bight will remain inthe suture holding region.

The automatic reloading of the second bight of suture onto the tissuepenetrator using the releasable hold (and suture holding region) isillustrated in FIGS. 13A-13G, showing a suture cartridge sequentiallypassing both a first bight region of suture 1031 a, and a second bightregion of suture 1031 b automatically (i.e., without having to reloadthe needle). For example, referring to FIG. 13A, the suture 1031 can bepreloaded into a cartridge or suture passer so that the first bightregion 1031 a extends through the suture engagement region 1067 of thetissue penetrator 1001, and the second suture bight region 1031 bextends around the tissue penetrator 1001 at the notch 1045 in the jawhousing 1043 adjacent to the tissue penetrator, and an end region of thesuture (the end region closest to the second bight region) is secured tothe tissue penetrator 1001 with the releasable hold (clasp 1055).

In FIG. 13B, the tissue penetrator 1001 preloaded with the first suturebight 1031 a is moved (e.g., slid) axially forward/distally as shown bythe arrow. As the tissue penetrator 1001 drives forward to deliver thefirst loop (bight 1031 a) between the jaws to the opposite jaw where itwill be held by a suture retainer, the second bight region 1031 b staysin place relative to the tissue penetrator 1001 in the suture holderregion (notch 1045) while the end of the suture 1035 moves with thetissue penetrator due to the clasp 1055. The second bight 1031 b staysin the notch 1045 while the adjacent end region of the suture buncheswithin the cartridge.

In FIG. 13C, the tissue penetrator 1001 is retracted proximally backinto the cartridge after delivering the first bight 1031 a of suture.The friction second bight in the suture holder region (notch 1067) holdsthe second loop region 1031 b relatively fixed while the end region 1035moves proximally away with the tissue penetrator. The suture bight 1031b is thus placed under tension as the region of suture between thesecond bight and the end of the suture held by the releasable hold istensioned. As shown in FIG. 13D, as the tissue penetrator 1001 is pulledproximally far enough so that the suture holding region (notch 1045) inthe jaw housing and the suture engagement region 1067 in the tissuepenetrator align, the second bight region is drawn into the sutureengagement region of the tissue penetrator. Because the second bight1031 b is under tension, aligning the notches 1045, 1067 cause thesecond bight 1031 b to slip proximally into the tissue engagement region(notch 1067) in the tissue penetrator, as shown in FIG. 13E.

In FIG. 13E, the second bight 1031 b has slipped fully into the sutureengagement region 1067 of the tissue penetrator 1001. In FIG. 13F, thetissue penetrator 1001 can again be extended distally to pass suture;before this step, the suture passer may be repositioned on (includingretracting the jaw/cartridge, etc.). Extending the tissue penetrator1001 distally pushes the second bight region between the jaw until italso engages a (or the same) suture retainer region on the opposite jaw.The tissue penetrator may again be retracted, leaving the second bightregion in the opposite jaw. In some variation the end 1035 of the sutureis pulled out of the releasable hold 1055 when extending the tissuepenetrator distally; alternately, the end of 1035 of the suture may bepulled out of the releasable hold 1055 when the lower jaw is retracted.The force required to pull the end region of the suture 1035 out of thereleasable hold may be much lower than the force retracting the lowerjaw. In general, when the releasable hold is maintained in a fixedposition relative to the tissue penetrator, the end region of the sutureis withdrawn by withdrawing the needle and/or the jaw housing (and jaw)proximally. Once the end region of the suture 1035 is released, thesuture body (in variations in which both bights regions of suture areformed in a single suture) may be pulled distally and out of thecartridge, as shown in FIG. 13G. The entire suture passer may bewithdrawn.

As mentioned, the cartridge can be disposable. That is, the cartridgecan be designed such that the entire jaw housing (including the tissuepenetrator) can be removed from the durable portion of the suture passerand discarded after it is used to automatically pass two loops ofsuture. Additional cartridges can be used with the suture passer foreach additional use. Advantageously, by using disposable cartridges,problems with tissue penetrator wear and/or fatigue can be reduced oreliminated.

FIGS. 14A and 14B illustrate loading of a preloaded cartridge onto asuture passer (a durable assembly of a suture passer) to form a loadedsuture passer that can pass two bights of suture. In FIG. 14A thecartridge 1403 is placed adjacent to the underside of the durableassembly 1401 of a suture passer, and the two are aligned so that akeyed region on either (or both) the cartridge and durable assembly.Once the keyed regions are joined, the cartridge may be slid proximallyrelative to the durable assembly to engage the two; a connector may beengaged to lock the cartridge to the durable assembly, forming a loadedsuture passer, as shown in FIG. 14B. FIGS. 15A-15E illustrate engagementof a preloaded cartridge 1503 to a durable assembly 1501 of a suturepasser to form the loaded suture passer. In FIG.15A, the cartridge 1503is brought near the underside of the durable assembly 1501, theengagement region (keyed regions) on the cartridge and the durableassembly 1501 are alighted (FIG. 15B), and the engagement regions arecoupled together to connect the cartridge to the durable assembly, asshown in FIG. 15C. In FIG. 15D, the cartridge is slid proximally untilone or more couplers on the cartridge are engaged with counterparts onthe durable assembly. For example, the jaw housing (e.g., the suturestorage region of the jaw housing) may be coupled to a rod, shaft, orother axially movable structure on the durable assembly that isconnected to a control (e.g., the lower jaw/needle extending controller1508). In addition, the tissue penetrator (not shown) may be coupled(e.g., via a needle sled) to a similar rod/shaft/axial needle actuatorthat is also connected to a lower jaw/needle extending control 1508, orother control.

Finally, in FIG. 15E the completed suture passer assembly may be used topass at least two bight regions of suture; the lower jaw (formed fromthe cartridge) may be extended and retracted, and the needle (tissuepenetrator) may similarly be extended and retracted.

FIGS. 16A-16C illustrate various examples of coupling mechanisms thatmay be used. For example, in FIG. 16A, the underside of the durableassembly of a suture passer is shown, showing a keyed region 1604 forreceiving a complementarily keyed region on a cartridge. For example, inFIG. 16A (and shown in greater detail in FIG. 16B) the durable assemblymay include an opening into which flanged wings on the jaw housing of acartridge may fit. Once inside the opening, the cartridge flanges mayfit into a track or channel 1606 that helps keep the cartridge alignedon the durable assembly. FIG. 16C also illustrates a coupler 1608 thatprojects from the underside of the durable assembly and can engage witha receiver on the cartridge (see, e.g., FIGS. 12A and 12B, receiverregion 1204). In this example, after engaging the keyed regions, thecartridge is slid distally until it engages with a retainer (coupler1608) that releasably locks the two together. In FIG. 16C, the coupleris a projecting, curved surface that slightly deflects the proximal endof the cartridge until it pops into the receiver region (opening 1204)in the cartridge housing (e.g., suture holding region). Thereafter, thecartridge forming the lower jaw assembly may be retracted so that thedistal end of the lower jaw formed by the cartridge is withdrawnproximally, or it may be extended distally (to extend the lower jawdistally). The cartridge may be removed by pulling the proximal end ofthe cartridge (e.g., the suture holding region) off of the coupler andsliding the cartridge forward to again align the keyed regions andseparate the cartridge from the durable assembly.

FIG. 17A illustrates another variation of a preloaded cartridge that maybe coupled with a durable assembly of a suture passer. In somevariations the cartridge is configured as a per stitch cartridge. Thecartridge may contain a segment of preloaded suture which may or may notinclude a pre-tied knot and some portion of the distal end of thedevice. FIG. 17A shows an embodiment where the distal cartridge 3007 iscomprised of the lower jaw component that contains the needle pathway,the needle, a needle sled (a connector that attaches the needle to atranslatable element in the handle 3003), and a suture (not visible).The same features that allow separation of the lower jaw into a distal(needle path) and proximal (acutation control) proitons that mayconnect/snap together may allow substnatial reductions in the deviceheight (e.g., the shaft height).

The proximal end of the cartridge may contain features that allow eachof the members requiring actuation, the needle and the lower jaw, toclick or snap into a corresponding actuator in the handle (See FIG.17B). An actuator on the handle can be activated by the user todisengage the connection features, facilitating removal of a usedcartridge and readying the handle for loading a new cartridge. Theadvantages of a per stitch cartridge include preloading the suture intothe cartridge so the surgeon or the scrub nurse do not have to deal withas much suture management in the sterile field, as well as keeping thesuture housed within the lower jaw so that it cannot get pinched betweenthe inferior surface of the device and the anterior horn of the meniscusor the tibia. Third, with both ends of the suture preloaded into thecartridge, the above architecture allows the surgeon to place both legsof the suture without removing the device from the joint. Thiseliminates the possibility of tissue bridging. Lastly, the durableassembly (including the handle) is re-usable throughout the case.

In FIG. 17B, the engagement region includes a housing engagementregion1755 at the distal end of the cartridge for engagement between thecartridge housing (forming the lower jaw) and the durable portion of thetissue penetrator (housing engagement region 1758), as well as a needle(tissue penetrator) engagement region 1766 at the distal end of thedevice that couples the tissue penetrator with a needle actuator (e.g.,slider/pusher) 1768 in the durable portion of the tissue penetrator1750. Thus, the cartridge may be adapted to engage two portions of asuture passer: a housing/jaw engagement region 1758 that holds thepreloaded/disposable lower jaw 1752 to the durable portion of the tissuepenetrator 1750 and a needle engagement region 1766 that couples with aneedle actuator 1768 in the durable tissue penetrator.

Although the variations described above include tissue penetrators(needles) that engage multiple lengths of suture with a jaw housing, insome variations the tissue penetrators and jaw may be differentlyconfigured. For example, FIG. 18A-18E illustrate one variation of alower jaw and tissue penetrator that are configured to be used as partof a suture passer that can hold and pass two lengths of suture. In FIG.18A, a jaw member (e.g., lower jaw member) that has a suture loadingregion 1803 adapted to hold a second length of suture while the firstlength of suture is held in a suture retainer region 1805 in the tissuepenetrator 1801. The jaw member shown in FIG. 18A is not yet loaded witha suture, and includes a central channel 1811 into which the suture maybe fed to load the device. The tissue penetrator 1801 is held within thejaw, and is configured to slide axially distally/proximally and can exitthe jaw member though a deflecting exit 1815 that directs the tissuepenetrator across an opening formed between the jaw members.

FIGS. 18B-18E illustrate loading of a pair of suture loops into thetissue penetrator and suture loading region 1803. For example, in FIG.18B, the first suture loop 1801 has been passed into the central channel1811 of the jaw member. This first loop of suture 1801 passes though thesuture loading region 1803 of the jaw member and into the sutureretainer or holder region 1805 in the tissue penetrator, as shown inFIG. 18C. This may be achieved by positioning the tissue penetrator at aparticular region within the jaw member so that the suture retainerregion 1805 is continuous with the edge (which may be curved) of thesuture loading region 1803 so that the suture passes into the sutureretainer region of the tissue penetrator. A second loop of suture 1808may then be loaded by again passing the loop over a portion of the jawmember and into the central channel 1811. The tissue penetrator may bemoved distally or proximally to make room for the second suture loopwithin the suture loading region 1803 without interfering with thesuture already in the tissue penetrator, as shown in FIG. 18D. Onceloaded, the tissue penetrator may be advanced slightly distally tosecure the two suture loops within the lower jaw, as shown in FIG. 18E.After the first length of suture has been passed to the opposite jaw andheld there, the tissue penetrator may then be extended back into jawmember and loaded with the second loop of suture, similar to FIG. 18C.

In some variations, the devices described herein may include one or moresuture management features such as suture tensioners, suture cleats,suture clamps, suture channels, and/or other structures that guide,hold, apply tension, and release the suture. These suture managementfeatures may be generically referred to herein as suture cleats.

A suture management feature such as a cleat and/or tensioner may be usedto hold one or more lengths of suture, and may generally aid inpreventing the suture from dropping off of the device and/or becomingtangled. A suture management feature may also help in automaticallyloading a length of suture in a tissue penetrator, as described above inreference to FIGS. 18A-18E. A suture management feature may maintainand/or control the tension on the suture as the device is operated. Forexample, a suture cleat may be biased (e.g., spring loaded) to maintaina relatively constant tension on the suture during operation, or may beused with a tensioning member (such as a tension arm or pin). Asmentioned, a suture management feature such as a cleat may include aprojection, pin, clamp, tensioner or other structure that holds thesuture (or multiple lengths of suture). Further, in some variations asuture management feature such as a cleat may be releasable, eithermanually or automatically, so that when a suture or multiple lengths ofsuture are secured by the cleat the suture(s) may be released from thecleat by triggering a cleat release.

As used herein, a suture cleat may include an opening into which thesuture may be held. For example, a suture cleat may include a projectionto which a length of suture may be secured. The cleat may hold thelength of suture by clamping the suture or by providing a typicallywedge-shaped opening into which the length of suture may be captured. Insome, but not all, variations the suture may be wrapped around thecleat. In some variation, the cleat may actively, e.g., by spring orbiasing member, pinch the suture(s) between one or more surfaces tosecure the suture(s). A suture may be removed from the cleat manually(e.g., by manually pulling the suture out of the cleat) orautomatically. For example, a cleat may include a pushing member thatpushes the suture out of the cleat. In some variations a projectingportion of the cleat may be configured to retract, e.g., into the jawmember, releasing any suture held therein. In some variations, aclamping portion of the cleat may be configured to release or relax anyclamping force holding the cleat. Release of a length of suture from thecleat may be triggered by an actuation mechanism including a mechanicalmechanism (e.g., lever, toggle, cam, etc.) or electrical/magneticmechanism (e.g., solenoid, motor, magnetic catch, etc.). In somevariations the cleat may be triggered to release a length of sutureduring a particular step in the operation of the suture passer. Forexample, the suture may be released from the cleat when the tissuepenetrator is retracted for reloading with a second bight of suture; thesuture cleat may release the suture so that a bight of suture can betransferred from a suture loading region in a jaw into a tissuepenetrator.

Thus, in variations in which multiple bights of suture are loaded in tothe device, a suture management feature may be used to hold and/ortension a second length of suture within the lower jaw member so that itmay engage with the tissue penetrator after the first loop of suture hasbeen passed. For example, FIG. 22A shows a distal portion of a lower jawmember 5901 and tissue penetrator 5903 into which two loops of a suturehave been loaded. A first loop 5905 has been loaded into the tissuepenetrator, and a second loop 5909 has been loaded into a suture loadingregion of the jaw, as described in FIGS. 18A-18E. The ends 5915, 5917are loose, as is the length of suture between the two bights 5913. Insome instances it may be beneficial to secure the free ends of the bight5909 that is loaded in the suture loading region 5917, 5913. It may alsobe advantageous to hold the second bight under tension. By securing theends 5917, 5916 of this second loop/bight 5909, and by holding it intension, it may be primed for automatically loading into the needleafter the needle has passed the first bight to the opposite jaw, asdescribed above. This is illustrated in FIG. 22B, showing the secondbight 5916 held taught with the ends of the bight 5916, 5917 (notvisible in FIG. 22B) secured to a suture cleat.

Pulling this second suture bight taught as shown in FIG. 22B by holdingthe ends of the suture bight in the cleat may help with automaticallyloading the second bight into the tissue penetrator, as illustrated inFIG. 22C. In this example, the tissue penetrator has been retractedproximally, exposing the opening of the suture retainer region. Tensionon the suture loop, as well as the shape of the suture holder region onthe jaw has driven the suture loop 5909 into the suture retainer region.Thereafter, the tissue penetrator may be withdrawn further proximally,and the suture cleat automatically (or manually) disengaged, releasingthe ends of the second bight so that the second loop is loose, thoughheld in the suture retainer region of the tissue penetrator, as shown inFIG. 22D.

FIGS. 22E-22H show a side view of the distal end of the lower jaw regionshown in FIGS. 22A-22D, in which the loose ends of the second bight aresecured (with slight tension) using a cleat. In FIG. 22E, which is aside view of a jaw member corresponding to the top view shown in FIG.22B, the free ends of the second suture bight are held in tensionagainst the lower jaw 5901 by a cleat 5920. The loop of suture is heldin slight tension, pulling the suture bight proximally within the sutureholding region and preventing it from falling out of the suture loadingregion which may also help pull it into the suture holding region of thetissue penetrator after passing the first bight. For example, in FIG.22F the lower jaw is shown adjacent to a region of tissue 5940; theupper jaw is presumed to be positioned on the opposite side of thisportion of tissue (not shown). The tissue penetrator 5930 is shownextending though the tissue, pushing the first bight through the tissue,while the second bight is held securely in the lower jaw by the cleat.FIG. 22G shows the device and tissue after withdrawing the tissuepenetrator, leaving the first bight in the tissue. The side view of FIG.22G corresponds to FIG. 22C. Thereafter, the tissue penetrator may beretracted proximally to engage the second bight so that it may be passedthrough a different region of the tissue. After retracting the tissuepenetrator and reloading it with the second bight, one or both ends ofthe second bight may be released from the cleat. In some variations thecleat holding the second bight may be configured to automaticallyrelease one or both ends of the suture, as illustrated in FIG. 22H. FIG.22H is a side view corresponding to the top view of FIG. 22C. In thisexample, retraction of the tissue penetrator (not visible) proximallymay trigger release of the suture from the cleat; in FIG. 22H, the cleathas been retracted into the lower jaw, dropping the lengths of suture.In some variations the cleat may pinch or engage the length(s) of sutureby a friction or grasping mechanism, and retraction of the tissuepenetrator and/or loading of the second bight onto the suture passer maycause the release of the lengths of suture from the cleat.

FIG. 23 shows a bottom view of one variation of a suture passer devicesimilar to the variation shown in FIGS. 1A and 1B, including a suturemanagement feature (a suture cleat in this example) securing the end ofa bight of suture that has been loaded into the suture passer. In thisexample, a suture cleat 6001 is located on the lower or second jawmember that is axially movable in the long axis of the device. Thus, asthe lower jaw is extended or retracted, the cleat moves with the lowerjaw. In some variations the cleat is a tensioning member that may adjustthe tension on the suture and/or suture loop. One or more suturemanagement features may be included on any appropriate region of thesuture passer, including the first jaw member, second jaw member, tissuepenetrator, elongate member, handle, etc.

As mentioned, a suture cleat may be configured to automatically releasea length(s) of suture, or reduce or release tension on the suture, whenthe second length of suture is ready to be loaded onto the tissuepenetrator. One example of an automatic release cleat is illustrated inFIG. 24A. In this example, the cleat holds two lengths of suture 6101,6102 securely against the outer surface of the lower jaw. In FIGS. 24Aand 24B the suture is shown only in cross-section, where they are heldand released by the cleat. For example, in FIG. 24A, the cleat 6105pinches the lengths of suture 6101, 6102 against the wall 6107 of thelower jaw member. In this example, the cleat is configured as a leafspring that is pre-biased against the lower jaw member; the distal endof the cleat is secured to the lower jaw. The cleat includes an internalcam surface 6115. Pushing against this cam surface may drive the cleataway from the wall of the lower jaw member, allowing the lengths ofsuture to be released, as shown in FIG. 24B. In this example, the cleatis automatically released when the cam surface 6115 is driven against acomplimentary release cam surface 6111 within the lower jaw. In somevariations, this release cam surface is part of the tissue penetrator.Thus, as the tissue penetrator is drawn proximally to load the secondbight, this release cam surface (formed as a region of the tissuepenetrator) drives release of the lengths of suture from the cleat. Insome variations, a separate lever or other mechanism may be used. Thecleat may also include a more active release mechanism, in which thelengths of suture are driven out of the cleat. For example, a releasecam surface may be driven into the cleat proximally as the tissuepenetrator is withdrawn proximally to load the second bight onto thetissue penetrator, and this release cam surface may drive the suturesout of the cleat.

FIGS. 25A and 25B illustrate another variation of a suture cleat,similar to the variation shown in FIG. 24A. In this example, the suturecleat 6201 is also attached at one side to the lower jaw of the suturepasser 6203, and a suture 6205 is held (clamped) in the jaws at theopposite end of the suture cleat 6201. The clamping region of the cleatmay be deflected away from the lower jaw, as shown in FIG. 25B. In thisexample, the suture (or multiple lengths of suture) can be clamped orheld in the long axis of the clamping region of the cleat. Opening theclamp region allows the suture to be released, as shown in FIG. 25B. Theclamp region of the cleat may be deflected by pushing against a camsurface that is connected to the clamping region. In FIG. 25B, the cleatincludes a region 6209 that can be used to deflect the clamping region.Thus, as just described, a suture passer may place two legs of acircumferential stitch with only a single insertion of the instrument.In some variations, the suture passer device may be loaded with two endsof a length of suture into one jaw (i.e. the lower jaw), inserting thesuture passer into the knee, having a tissue penetrator pass one sutureend up to the other jaw (i.e. the upper jaw) where it is removed off ofthe tissue penetrator. The tissue penetrator may then return to thelower jaw and pick up the second end of the length of suture. Theinstrument is placed in another location, and the tissue penetrator isagain advanced, passing the suture off onto the upper jaw. With bothends of the suture having traveled from the lower jaw to the upper jaw,removing the suture passer will result in a circumferential stitcharound the tissue.

In the above embodiment, one configuration for loading two ends of asingle suture into the suture passer so that a single tissue penetratorcan pass them with sequential advances of the tissue penetrator involvesspecific jaw features. For example, the lower jaw may contain a trackfor guiding the tissue penetrator. One section of the track is cut outleaving a space for a second suture to reside beyond the width of theneedle. The space (suture holding region 1803) is identified in FIG.18A.

In some variations the device includes a control (e.g., switch, lever,button, etc.) that moves the tissue penetrator to assist in loading. Forexample, a suture passer including a proximal handle is shown in FIGS.1A and 1B.

The procedure for loading a suture passer may include first loading oneend of the suture into a notch contained on the tissue penetrator (e.g.,FIGS. 18A-18C). A suture can be pinched in place by pulling the tissuepenetrator back. Next the other end of the suture may be loaded into thespace that is cut out of the tissue penetrator guiding track. Thissecond end of the suture is pulled taught away from the tissuepenetrator as shown in FIG. 18D. While the second end is pulled taughtinto this space away from the tissue penetrator, the user flips a switchon the handle causing the needle to move distally a small amount.

In some variations, the suture passer is configured to be loaded withone or more sutures so that the bights of the two ends of the sutureboth reside on the superior surface of the lower jaw. FIGS. 19A and 19Billustrate schematically two variations in which both legs of a loop ofsuture are held on the same side of the device (e.g., the superiorsurface of the lower jaw) when loaded. These embodiments may includetissue penetrators that have two notches, allowing a suture to wraparound the tissue penetrator so that the suture can originate on thesuperior surface of the lower jaw, wrap around the tissue penetrator,and return on the superior surface of the lower jaw. FIG. 19A shows atissue penetrator having two notches (adjacent to each other) on oneside of the tissue penetrator, and FIG. 19B shows a tissue penetratorhaving two notches on opposite sides of the tissue penetrator. In bothcases the suture loop may wrap around the tissue penetrator so that thelength of suture before and after the loop region extends on the sameside or surface of the suture passer. In both examples, the jaw in whichthe tissue penetrator resides is also adapted for loading the two ormore sutures, and may include a suture loading region (or regions) tohold a suture loop until the suture holder in the tissue penetrator isempty of another suture.

In some variations multiple loops of suture may be sequentiallydelivered with a tissue penetrator in which the tissue penetrator hasmultiple suture retainer regions. In some variations the suture retainerregions are configured as one or more notches. The suture retainerregions may be positioned along the proximal to distal length of thetissue penetrator. For example, in some variations, a second sutureretainer region is positioned proximal to a first suture retainer regionalong the length of the tissue penetrator. In this variation, an exampleof which is shown in FIG. 20 , the proximal handle of the suture passermay coordinate travel of the tissue penetrator so that to pass the firstloop of suture in the distal most suture retainer region of the tissuepenetrator, the distal suture retainer (e.g., notch) passes the suturestripper in the upper jaw while the second suture does not (by limitingthe distal extension of the tissue penetrator). This is shown in FIG. 20. The second loop of suture is passed by (e.g., via a control on thehandle or automatically) advancing the tissue penetrator more distallyso that the more proximal suture retainer region on the tissuepenetrator extends past the suture stripper in the upper jaw, trappingboth the first and second loops of suture. Another variation of a suturepasser adapted for passing at least two loops of suture (eithersequentially or simultaneously) is shown in FIG. 21 . In this example,two tissue penetrators are included in parallel, each one loaded with asuture. In some variations the tissue penetrators are side-by-side asshown in FIG. 21 ; alternatively, the tissue penetrators may be atopeach other. The sutures may be delivered by extending each (or both) ofthe tissue penetrators across the tissue and into the second jaw memberwhere a suture stripper can retain the suture(s).

In operation, the preloaded suture passers described herein may be usedto suture any appropriate tissue, not limited to knee (e.g., meniscus,ACL, etc.), hip (e.g., hip labrum, etc.), shoulder (e.g., rotator cuff),etc. For example, FIGS. 26A-26L illustrate one method, includingoptional steps, of using a preloaded suture passer to repair tissue; inthis example, the meniscus includes a tear 2609 which may becircumferentially stitched by placing a first end of the suture throughthe meniscus on one side of the tear, and placing the opposite end ofthe suture on the other side of the tear.

In FIGS. 26A and 26B, the suture passer is first assembled by coupling apreloaded cartridge 2603 with a durable assembly 2605 to form a suturepasser 2601. In FIG. 26C, the suture passer is positioned adjacent tothe target (torn meniscus) tissue; in this example, the upper jaw of thesuture passer is pivotable/bendable relative to the elongate axis of thedevice, and the lower jaw is axially retracted (proximally) so that thetip of the suture passer has a very narrow profile and can fit into thenarrow confines of the anatomy. In FIG. 26D, the lower jaw is extendeddistally to surround the torn meniscus. In FIG. 26E the tissuepenetrator 2611 is extended from the lower jaw (from the cartridge) tothe upper jaw while pushing a first bight region of suture. The tissuepenetrator is then retracted, leaving the first bight region of sutureat a first end of the suture held in the suture retainer region 2618 ofthe upper jaw, as shown in FIG. 26F. The suture 1615 then extends fromthe upper (superior) side of the meniscus and the upper jaw to the lower(inferior) side of the meniscus and the lower jaw. Withdrawing thetissue penetrator into the lower jaw housing (shown in FIG. 26E) mayautomatically re-load the tissue penetrator with the second bight ofsuture near the distal end of the suture, as discussed above. Forexample, when the second bight of suture is held in a fixed position andthe distal end region of the suture next to the second bight is held ina releasable hold on the tissue penetrator, the tension pulling thesecond bight proximally may pull the second bight into the sutureengagement region (now empty) on the tissue penetrator. Thisautomatically re-loads the tissue penetrator with a second bight oftissue.

In FIG. 26G the suture passer is repositioned on the meniscus so that itcan suture on the more apical side of the tear 2609. Once positioned,the suture passer is again activated (e.g., by actuating the lowerjaw/needle extension control on the handle) to drive the tissuepenetrator from the lower jaw through the tissue to the upper jaw, wherethe second bight region also engages with a suture retainer 2618 in theupper jaw. The same or a different suture retainer may be used.Withdrawing the tissue penetrator again leaves the second length 2619 ofsuture behind in the meniscus, as shown in FIG. 26H. Thereafter, thelower jaw can be retracted, leaving the suture “slack” 2622 (the suturebody) on the inferior side of the meniscus, and allowing the loop to beclosed by withdrawing the suture passer (including the upper jaw) fromthe knee, as shown in FIG. 26J. A knot pusher (not shown) can then beused to tighten and tie a knot in the loop of suture, repairing thetear, as shown in FIG. 26K. The cartridge may then be removed from thedurable assembly, as shown in FIG. 26L, and another (new) cartridge maybe applied.

Pre-Tied Suture Knots

Also described herein are pre-tied suture knots that may generally beused with any of the suture passers (including suture cartridges)described herein. In some variations, a suture having a pre-tied knot(and the knotted apparatus forming the pre-tied knot) may be loaded intothe device, e.g., in the cartridge of the device, so that the suture maybe passed through tissue using the suture passer as describe above. Oncethe length of suture (or multiple lengths of suture) has been passedthrough the target tissue, the pre-tide knot may be pushed down tosecure the length of suture in the tissue. For example, an end region ofone or both (in variations in which two lengths of suture are beingpassed) lengths of suture may include a pre-tied knot, and the sutureincluding the pre-tied knot may be passed through the tissue by thetissue penetrator. In some variations the pre-tied knot includes aleader snare. For example two lengths of suture (from the same elongatesuture) may be passed through a tissue; in some variations, both lengthsmay be pre-knotted (e.g., may include a pre-tied knot), however only oneof the pre-tied knots may include a leader snare and may be configuredto allow another length of suture to be pulled through using the leadersnare.

Any of the cartridges described herein may be pre-loaded with a lengthof suture and a length of “snare” material so that a loop or bight ofsnare and a loop or bight of suture may each be passed and may beconsecutively and automatically loaded into the needle for passing bythe suture passer. In general, a snare may be a filament material,similar or identical to the suture material, or in some variations adifferent material (e.g., having a different composition and/or diameterand/or surface property). The snare may be configured so that it forms aloop or bight, and the loop cannot be opened as with the bight of suturethat is passed. For example the loop forming the snare may be closed atboth ends, or at one end forming the loop.

The pre-tied knot systems described herein may also include a knottedregion (“knot” or “knot system” or “knot former”) that can be pusheddown the suture to secure (knot, tie, or form the knot or tie). The knotforming may formed of a suture or suture material, or it may be formedof a differnet material. See, e.g., US20140074157, herein incorporatedby reference in its entirety. The knot or knot former may also bereferred to as a pre-tied knot body and may be formed from suturematerial at a region on the pre-loaded suture. The knot or knot former(aka pre-tied knot body) may be formed of one or more loops of thesuture material, wherein each loop has at least one crossing point; andthe leader and/or the suture forming the bight of suture within thecartridge may pass through the pre-tied knot body (e.g., the loops).

For example, FIG. 51A shows one example of a pre-loaded suture cartridgeas described above. In this example, the pre-loaded cartridge isconfigured to connect to a suture passer to form the movable, e.g.,slideable, lower jaw member. A pre-tied knot system, including a suture,a snare (aka leader) and a pre-tied knot body, is loaded into thereplaceable cartridge, as illustrated in FIGS. 51B and 51C. In FIG. 51B,the pre-tied suture knot system shown within the cartridge. In FIG. 51C,this pre-tied knot system includes a primary suture 5101 and a snare5103, as well as pre-tied knot 5105. The suture and snare are connectedwithin the cartridge by the pushable pre-tied knot body 5105. Thecartridge is configures so that the snare is preloaded (and will bepassed first) into the tissue penetrator (needle) and the suture ispoised to be automatically loaded after the snare (bight) is passed.

Thus, in some variations, the snare 5103 may form a first bight and theprimary suture 5101 may form the second bight (or vice-versa). Tooperate a suture passer having a cartridge pre-loaded with a pre-tiedsuture knot (knot system), the first and second bights (e.g., both thesnare and the primary suture) may be passed through differnet regions ofthe tissue and a free end of the primary suture may be manually orautomatically be threaded into the snare and the snare withdrawn fromthe tissue to pull the suture back through the tissue a second time,along the path formed by the snare, looping around the tissue andthrough the pre-tied knot, so that the pre-tied knot can be pushed (orpulled) down to cinch the suture around the tissue. For example, a firstbight of the snare loop may be passed through the tissue in a firstlocation by the tissue penetrator of the suture passer. The suturepasser can then be moved and the tissue penetrator automaticallyre-loaded with a bight of the primary suture; the bight of primarysuture may then be passed (pushed and/or pulled) through the tissue at adifferent, e.g., adjacent, location by the tissue penetrator of thesuture passer, and the distal end of the suture may be withdrawn(including withdrawn completely out of the tissue) and passed throughthe loop region of the snare (e.g., in some variations, the bight regionof the snare that has been passed through the tissue). The snare maythen be withdrawn from the tissue, pulling the end of the primary sutureback through the tissue; the snare may also be pulled through thepre-tied knot, pulling the distal end of the primary suture with it.Once the snare is removed, the pre-tied knot can then be pushed distallyto cinch the knot. This is illustrated in FIGS. 52-54C and (as a viewfrom within the tissue) in FIGS. 55A-55E.

For example, in FIG. 52 , the suture passer having a pre-loadedcartridge that is loaded with a pre-tied knot system such as the oneshown in FIG. 51A-51C, is inserted into the body so that the tissuepasser can be paced adjacent and/or around a target tissue. In thisexample, the target tissue is a meniscus, though it should be understoodthat any appropriate target tissue may be treated, including shoulder,hip (labrum), tendon, etc. The distal end of the suture passer device,with the cartridge pre-loaded with both suture and knot pushing systemis inserted into an opening in the tissue as illustrated. As shown inFIG. 52A, the suture may then be operated as described above to pass afirst bight (e.g., a bight of snare or “leader” portion 5103) throughthe tissue. Thereafter, the distal mouth of the suture passer may bepositioned around a different region of the tissue, as shown in FIG.53B, so that the suture passer can pass a second bight of tissue (e.g.,a bight of the primary suture) through the target tissue at a differentregion. This example illustrates the tissue passer passing the suturebight from the inferior to the superior surface, so that the bight iscaptured by the upper arm of the suture passer after leaving thesuperior surface of the meniscus. Once both loops (bights) are passed,the suture passer can then withdraw slightly or completely out of thepatient, as shown in FIG. 53C. As the suture passer device is withdrawnfrom the tissue (e.g., knee), one end of the primary suture 5101 may bepulled free. For example, the distal end of the primary suture may bereleased from the tissue penetrator, either manually (e.g., using ahand/finger or assisted by a probe or other tool). As shown in FIG. 54B,the pre-tied knot may also be pulled from the cartridge. The free end ofthe primary suture may be passed through the loop of the snare, snaringthe primary suture, allowing the snare to be withdrawn from the tissue,and to pull the free (e.g., distal in this example) end of the sutureback through the tissue in the path taken by the snare and then throughthe pre-tied knot, as shown in FIG. 54C. The suture (e.g., the proximaland/or distal end of the suture) may then be held taut while thepre-tied knot is pushed down to tighten over the tissue. This is shownin detail in FIGS. 55A-55E. In FIG. 55A, the snare 5505 is used to pullthe primary suture 5503 through the tissue, as shown in FIG. 55B. Theprimary suture 5503 can then be pulled through the pre-tied knot 5507,as shown in FIG. 55C. In FIG. 55D the knot may be pushed to slide downthe primary suture until it is secured near the tissue, which as shownin FIG. 55E in this example is a meniscus in the knee. In this example,the knot is formed on the underside (inferior surface) of the meniscus,which may be beneficial.

Also described herein are features and improvements that may generallybe used with suture passers having upper and lower jaws, even whereneither jaw is configured to be removable/reloadable.

In some variations a knot of suture may be passed through tissue using asuture passer as describe above in which a pre-tide knot is used to helpsecure the length of suture being passed to the device. For example, insome variations an end region of one or both (in variations in which twolengths of suture are being passed) lengths of suture are knotted, andthis pre-tied knot may be passed through the tissue by the tissuepenetrator. The pre-tied knot may or may not include a leader snare. Forexample, in some variations two lengths of suture (from the sameelongate suture) may be passed through a tissue; both lengths may bepre-knotted, however only one of the pre-tied knots may include a leadersnare and be configured to allow another length of suture to be pulledthrough using the leader snare.

In some variations, the suture passers described herein may include asecond (e.g., lower) jaw that is thin (e.g., <0.11 inches in diameter atthe widest point). In general, thinner second jaws may be inserted intonarrower and difficult to access body regions. In some variations, inwhich the second jaw houses the tissue penetrator and the tissuepenetrator extends across the distal-facing opening formed between thefirst and second jaw, the second jaw may include a deflection ramp ordeflection structure to help deflect the tissue penetrator out of thejaw and across the distal-facing opening. The deflection ram ordeflection structure in some variations may form a widened region of thesecond jaw. Although it was initially believed that this enlargeddeflection region was necessary to provide sufficient deflection andcontrol of the motion of the tissue penetration, recent informationsuggest that this may not be necessary, particularly when using apre-bent or pre-biased shape memory material to form the tissuepenetrator. Thus, as shown in FIGS. 27A to 27C, second jaws housing atissue penetrator may be used, wherein each one has a differentthickness and/or different size deflection region. For example, in FIG.27A the second jaw includes a deflection region 2707 distal to theopening from which the tissue penetrator may be extended (extension of atissue penetrator is illustrated in FIG. 27D). The widest diameterportion 2701 of the jaw in this example is the deflection region 2707.In some variations the widest diameter region is less than approximately0.15 inches (e.g., less than about 0.14 inches, less than about 0.13inches, less than about 0.12 inches, less than about 0.11 inches, lessthan about 0.10 inches).

Although a protruding deflection region may be helpful for steering thetissue penetrator/needle as it leaves the jaw, surprisingly, in somevariations a protruding deflection member is not necessary, allowing thediameter of the jaw to be thinner. For example, in FIG. 27B, a jawhousing a tissue penetrator is shown without a protruding deflectionmember. FIG. 27E shows the jaw of FIG. 27B with a tissue penetrator 2705extending from the side of the jaw. In this example, the jaw is thinnerthan the example shown in FIG. 27A; the maximum diameter (e.g., maximumheight) of the jaw 2711 is less than about 0.10 inches (e.g., less than0.09 inches, less than 0.08 inches, less than 0.07 inches, less than0.06 inches, etc.). FIG. 27C shows another example in which the jaw iseven thinner (e.g., less than 0.06 inches, less than 0.05 inches, lessthan 0.04 inches, less than 0.03 inches, etc.). In any of these examplesthe jaw may have a width. For example in some variations the width isbetween about 0.01 inches and about 0.15 inches. The tissue penetratoris typically thinner and narrower than the jaw so that it may fit withinthe jaw; the tissue penetrator (e.g., needle) may have a square, round,rectangular, or other cross-sectional area. In general, the tissuepenetrator may be configured as a ribbon-shaped tissue penetrator,having a sharp (e.g., pointed, beveled, etc.) distal tip region, and asuture retaining region (e.g., hook, eyelet, etc.).

Any of the jaws illustrated in FIGS. 27A-9F may be used as a second orlower jaw for a suture passer as illustrated above (e.g., FIGS. 5A-6B).In general, any of the suture passers described herein (including thosewith removable jaws) may include first and second jaws having atraumatic(e.g., non-tissue penetrating) distal tip regions. Thus, as illustratedin these figures, the distal tip region of both jaws (first and second)may be rounded and atruamatic so that they do not readily penetrate orcut the tissue. However, in some variations, the distal tip region of ajaw is tissue penetrating, allowing the jaw to be inserted into thetissue. In particular, it may be beneficial to have the axiallyslideable jaw (e.g., the second jaw) be tissue penetrating so that itcan be extended into the tissue. This may allow the suture passer topass a suture in an angle within the tissue (including at a right angle,e.g., to form an approximately “L” shape).

A mentioned above, it may be beneficial to minimize the height of thedistal end, and particularly the lower jaw and/or upper jaw at thedistal end of the device. It may also be beneficial to reduce the heightof the elongate body of the device. Described herein are designsconfigured to provide minimal height to the elongate body and/or lowerand/or upper jaw.

For example, in some soft tissue repair situations, getting access intotight spaces is necessary for accessing the soft tissue requiring repairand for preserving the tissues adjacent to the repair site. An exampleis a torn meniscus where the knee ligaments can limit the space betweenthe femur and tibia to as little as 3.5 mm. The femur and tibia arecovered in cartilage which must be preserved in order to maintain properjoint health. Therefore a suture passer that has a shaft height of 3.5mm or less provides significant clinical utility to the surgeon. In asuture passer embodiment that contains a sliding lower jaw, as describedabove, the minimum height is dictated by minimizing specific dimensions.For example, FIG. 43A shows a cross-section through a variation of asuture passer having a sliding lower jaw. Exemplary dimensions thatcontribute to the overall device height include: the height of the lowerjaw 4305 in order to contain the needle pathway, the height of theneedle shaft 4311, the height of the clamp rod 4309, the height of theshaft 4307 necessary to maintain appropriate strength, and the height ofthe clamp link 4313. These heights are illustrated in the enlarged viewsof the lower jaw (FIG. 43B), elongate body (FIG. 43C), and clamp link4306 region (FIG. 43D). Even a small reduction in any of these heights,without sacrificing the performance parameters, may provide substantialgains in how and where the suture passer may be used.

For example, in one variation, a number of architectural changes may bemade that facilitate a shorter overall height of the instrument. First,the lower jaw pathway may be truncated so that the arc in the lower jawdoes not turn fully to 90 degrees, as previously described. See, e.g.,FIG. 43B. If, instead, the needle may be configured to exit the lowerjaw at a shallower angle (<90°, such as approximately 80°, approximately70°, approximately 60°, etc.) while still contacting the upper jaw in aregion sufficient for deflection distally to pass the suture asdescribed above.

In some variations, a structural portion of the shaft that connects thetwo sides of the shaft together has been moved from the top to thebottom. This change is facilitated by breaking the lower jaw into twopieces, a first (e.g., distal) end part that contains all of thefeatures of the needle pathway, and second (e.g., proximal) part thatserves to translate the position of said distal end. The second, moreproximal, piece is not as tall as the distal piece so that it can nestwithin the shaft. The jog in height is shown in FIG. 44 . In thisexample, the distal end 4407 of the lower jaw contains the needlepathway, while the proximal end 4405 include the strucutre spine of theshaft. The transition between the two 4409 allows for a very flatprofile.

In some variations, the height of the needle shaft and clamp rod arereduced. The clamp rod may move to actuate the hinged upper jaw. Forexample, the clamp rod 4501 may be made flat and attached to the shaft4509 using a tongue-in-groove configuration while communicating throughthe open top in the shaft 4509, as illustrated in FIG. 45A. The needleshaft 4503 passes below the clamp rod over this protion of the elongatebody. The lower jaw translation shaft 4505 is a U-shaped element withinthe shaft 4509 that partailly surrounds the needle shaft 4503. Thecombination of these features minimize the amount of material needed tokeep the necessary strength and rigidity.

In some variations, the clamp link (which contributes to the hindgedmotion fo the upper jaw) is changed from having two holes with pinsthrough them as shown in FIG. 6D to an alternate design that replacesthe more proximal hole with a pin that is integrated into a the clamplink such that it mates with the clamp rod in a the manner shown in FIG.45B.

Thus, any of these features may be combined to reduce the height of thesuture passer devices having an elongate shaft, as shown. For example,the elongate body may have a U-shaped cross-section. The upper jawactuator (“clamp rod”) may be coupled to the hinge (clamp link) via arecessed connection within the footprint of the elongate shaft at oneend, and within the upper jaw at the other end, as shown in FIG. 45A.Further the lower jaw member may include a distal region that controlsthe needle actuation and a proximal region that includes the linearactuating components.

FIGS. 46A-46B and 46A-47B compare a device that does not include theU-shaped outer housing and recessed hinge (FIGS. 46A, 47A) with a devicethat does (FIGS. 46B, 47B) in top (FIGS. 46A-46B) and bottom (47A-47B)perspective views.

Passing a Loop of Suture Through Tissue

Any of the suture passers described herein may be used to pass a suturein a loop though tissue, so that the ends of the suture can beapproximated (e.g., tied together, anchored, etc.). In some variationsthe suture passer may be loaded with a first length of suture, the firstlength of suture passed through the tissue, then the suture passer canbe reloaded with a second length of the suture and repositioned, and thesecond length of the suture can then be passed through the tissue again.

For example, FIGS. 28A-28K illustrate on method of forming a loopthrough tissue in a meniscus using a device that only passes a singlelength (e.g., bight) of suture. As illustrated, a suture passer can beinserted through a working portal and advanced until the upper jaw isbetween the superior surface of the meniscus and the articular surfaceof the femoral condyle (FIGS. 28A-B). The lower jaw is then extendedforward so that it moves under the meniscus and the tissue penetrator(needle) trigger is actuated to complete the peripheral pass of thesuture from the lower jaw to the upper jaw where it is atraumaticallyself-retained (FIG. 28C). The lower jaw is retracted and device isremoved (FIG. 28D). The suture passer is then re-loaded with theopposite suture strand and re-inserted while gently pulling on thesuture such that the upper jaw is lead into the exact same tissue plane(FIG. 28E) the suture is again passed from lower jaw to upper jaw, thistime positioned on the opposite side of the tear (FIG. 28F), and thelower jaw is again retracted and the device removed (FIG. 28G). A knotcan then be tied on the peripheral femoro-synovial junction (shown inFIG. 28H). No cannula or sled is required for this technique, and themethod avoids tissue bridging that can occur if the suture re-enters thetissue in a slightly different location.

As described above, the suture passer may be adapted so that the devicedoes not need to be withdrawn out of the tissue to be loaded with thesecond suture, including pre-loading the first and second (or more)lengths of suture. In addition, or alternatively, the suture passer maybe adapted so that the tissue penetrator (needle) is adapted for bothpushing a suture from the lower jaw to the upper jaw and pulling suturefrom the upper jaw back to the lower jaw (or vice-versa).

The suture passer devices described herein may be configured so that theend of the suture, or a suture linked element connected to the suture,is first pushed by the tissue penetrator through the tissue from thefirst (e.g., lower, axially moving) jaw to the second (e.g., upper,bending) jaw, then the device is moved relative to the tissue and thetissue penetrator is then extended to collect the end of the suture orthe suture linked element, and retracted back through the tissue to pullthe suture back through the tissue. Thus, a full stitch may be passedthrough the tissue. In the meniscus, the full stitch may be passedwithin the joint capsule without removing the device between passes.

An exemplary sequence of operation is as follows: with a suture loadedonto the device, the device is inserted into the joint capsule and placethe device in position for the first pass; pass (“fire”) the first legof the suture; move the device to the second location; fire the deviceto retrieve the suture, and remove the device from the joint capsule.The suture can then be released from the device and the knot tied(closing the suture loop). This method and devices for implementing itmay be referred to as “push/pull” since one end of the suture is first“pushed” through tissue by the needle and captured in the upper jaw, andit is then moved to the second position, and the needle comes up throughthe tissue to retrieve the captured end and pulls it back down into thelower jaw.

In a first variation shown in FIGS. 29A-29D, a suture that is loadedinto the suture passer containing a suture retaining plate on the secondjaw that is configured to releasably hold the distal end of a suture,where the plate is adapted to have a “keyhole” passage 2901 throughwhich the suture may be entered and temporarily retained. In somevariations this retaining plate with the keyhole is a stripper plate asshown and described above, but with the addition of the keyholestructure. In some variations the keyhole retaining plate is positionedadjacent to a suture stripper. This keyhole suture retainer on the plateand/or suture stripper has an opening at one end that has a largerdiameter than the suture; the passage connecting the edge of the suture(which may have a large mouth 2905 that narrows to the narrower passage)typically has a narrower diameter (D_(p)). The keyhole passage typicallyincludes a bend or bends (elbow region) before opening into the largeopening mentioned. The elbow region may retain the suture in this narrowregion until the tissue penetrator extends back across to retrieve it,as will be described below. FIG. 29A illustrates one variation of asuture stripper 2901 with such a keyhole passage. This variation may beused with a suture having an enlarged distal end feature, such as aknot, ferrule, or other enlarged region attached to the distal end (ornear the distal end) of the suture. One embodiment of this enlargeddistal end feature of the suture is an overhand knot tied at the end ofthe suture. A second embodiment is a plastic or metal part that isovermolded, glued, tied or otherwise affixed to the end of the suture.In this embodiment, the stripper with the keyhole cutout may capture theenlarged region of the suture on the end of the suture. As describedabove, the adapted suture stripper is attached to the inferior surfaceof the upper jaw. See, e.g., FIGS. 29A-29C. The keyhole cutout region2905 is shaped in a fashion that allows it to hold the suture at variousstates while facilitating release of the suture during the second phase(pull) of the procedure. The keyhole-adapted stripper 2901 may be madefrom any appropriate material, including plastic or sheet metal.

FIG. 29B shows the distal end of a suture with an upper jaw member thatincludes the plate having a keyhole opening. In this example, a separatesuture stripper 2909 is positioned above the plate with the keyholefeature. A tissue penetrator may pass under the suture stripper and theplate with the keyhole feature and the stripper scrapes the suture offthe tissue penetrator as the tissue penetrator retracts. FIG. 29Cillustrates a top view of the upper jaw of FIG. 29B, showing the distalend of the jaw, with the opening 2905 into the keyhole region thatnarrows to guide the suture into the bend/elbow region and eventually tothe larger opening. FIG. 29D shows the distal end of the suture passerafter the suture with the enlarged distal end feature 2905 has beendeposited into the keyhole cutout 2901 of the upper jaw.

FIGS. 30A-30B illustrate operation of the plate with the keyhole cutoutfeature 3001 and a suture with an enlarged distal end feature 3005. InFIG. 30A, the needle is shown beneath the trap feature (the keyholecutout 3001), which has been made transparent to show the needleposition. The enlarged distal end feature 3005 enters the keyhole cutoutthrough the large opening at the edge. The needle passes the first legof the suture and the knot at the end of the suture (enlarge distal endfeature 3005 of the suture). The needle then retracts, leaving the knotand suture behind, and tension is applied to the suture to locate itsecurely in the correct position, as shown in FIG. 30B. FIG. 30C shows aside perspective view of the method being applied in a meniscal tear(tissue 3011 with tear 3014). The suture passer may be placed in asecond location on the meniscus (e.g., without removing it from the kneejoint or having to reload) where the second suture leg is intended to bepassed. The needle may then be passed through the tissue, and the angledregion 3016 at the tip of the needle pushes the suture into the releasepathway of the keyhole cutout region 3001, which is shown as an enenlarged circular region. The release pathway is typically an openinghaving a larger diameter than the enlarged distal end feature of thesuture. The release pathway may also include a channel or ramp on theplate that guides the suture to the enlarged opening. This isillustrated in FIGS. 30G and 30H. FIG. 30H shows the needle just beforeit picks up the suture on its way back to the lower jaw. FIG. 30I showsthe needle with the suture (and enlarged distal end feature 3005) heldwithin the hook region of the needle.

As illustrated above, the needle (tissue penetrator) used for any ofthese procedures may be adapted to include a suture “pushing” region(hook region, etc.) and a suture “pulling region” (hook region). Thesuture pushing region is typically located more distally than thepulling region. In FIG. 30E, the needle has a distal-end adapted with apushing region in which a notch is cut out of the distal end to hold thesuture (and enlarged distal end region) as it pushes through the tissue.Proximally along the needle, a hook region, which is oriented so thatthe hook opening extends distally, is adapted for pulling the suture(and enlarged distal end region) back through the tissue towards thelower jaw. FIG. 30F illustrates another example of a needle in which thepushing region is not at the distal-most end, but is located proximal tothe distal end. The needle includes a ramped region at the distal end.

FIGS. 31A-31D show a profile view of the procedure using the keyholecutout plate and the suture having an enlarged distal end feature. InFIG. 31A the suture passer is positioned around the meniscus, aspreviously described. Once the lower jaw is extended, preloaded with thesuture with a knot (e.g., enlarged distal end region 3101, not shown toscale), the tissue penetrator may be extended, as shown in FIG. 31B, topush the suture through the meniscus on a first side of the tear in themeniscus 3105. The suture is retained in the keyhole cutout plate, andthe suture passer may be repositioned on the meniscus, as shown in FIG.31C (also not shown to scale). The needle may be extended back throughon a second side of the tear (e.g., opposite from the first side), sothat the knot is pushed by the returning needle into the large openingof the keyhole cutout plate (not shown) and captured by the pulling hookof the needle and withdrawn back through the tissue with the retractingneedle, as shown in FIG. 31D. It should be understood that the terms“needle” and “tissue penetrator” are used interchangeably in thisdisclosure, though the broader “tissue penetrator” term applies.

Another variation of a suture passer configured as a push/pull suturepasser for forming a loop is shown in FIGS. 32A-32D. In the variation,the device includes a suture passer similar to those described above inFIGS. 5A-6D, but adapted to include a releasable snare. In FIG. 32A, thesnare is shown having an open loop 3201 around the distal-facing openingof the upper jaw. The snare may be housed on the side of the device andretractable into this housing (e.g., snare guiding tube 3207). Theopening of the snare loop 3201 may be positioned to accept the first legof a suture. After the first leg is passed, the snare loop 3201 can betightened and cinch the suture, thereby securing it to the device as itmoves to the next position. The loop of the snare may be cinched bypulling the snare proximally so that the loop enters into the housingand closes over the suture, as described below. Once in position, theneedle comes up again through tissue to retrieve the suture. The snarethen then release, and the needle may be pulled back through the tissueto the lower jaw. FIGS. 32B-32D illustrate these steps. In thisvariation, the snare may be a wire snare (e.g., Nitinol, stainlesssteel, etc.), which runs through tubing alongside of the device. In FIG.32B, the first leg of the suture has been passed through the tissue (notshown) and up through the snare opening. In FIG. 32C, the snare ispulled so that it retreats into the tunnel (snare guiding tube) alongthe side of the device, bringing the suture with it, and securing thesuture in the closed loop, at least partially held within the narrowconstrains of the snare guiding tube, while the device is repositioned.Finally, in FIG. 32D the snare loop may release its hold on the sutureby extending the wire snare out of the snare guiding tube. The needlemay be “fired” (sent across the tissue to the upper jaw) this timehooking the suture. Since the suture has been released by the snare, thesuture is free to be pulled back through the tissue by the tissuepenetrator and into the lower jaw.

FIGS. 33A-33D show an illustration of this method applied to a meniscus.After positioning the suture passer around the meniscus (shown in FIG.33A), the suture is pushed through the tissue to the upper jaw, wherethe suture passes through the snare opening (not shown) and the snare ispulled distally to capture the suture and hold it in the upper jaw whilethe suture passer is repositioned, as shown in FIG. 33C. Finally, thetissue penetrator is passed through the tissue again, the snare loop isreleased, and the tissue penetrator hooks and retracts the suture,withdrawing it back through the tissue to the lower jaw (FIG. 33D).

FIGS. 34A-34G illustrate another variation of a system and device forpassing a loop of suture through the tissue. In this example, the sutureis coupled at or near its distal end with an expandable capture elementthat makes it easier for the needle to recapture the end of the sutureand pull it back through the tissue after it has already been passedthrough the tissue a first time. The capture element is typicallyexpandable and collapsible, so that it present a small profile withinthe suture passer and/or within the tissue as it is being passed, butexpands or opens to form a relatively large, and easy to capture profileonce it has been passed through the tissue a first time. The suturepasser may be adapted to hold and grab the expandable capture element.The capture element may be connected to a suture in any appropriatemanner, including by tying, gluing, crimping, etc.

Any appropriate capture element may be used, including loops, baskets,coils, etc. The capture element may be flexible, and may be formed ofmetal, plastic, or the like. For example, in some variations the captureelement is formed of a Nitinol wire. A flexible loop or basket (e.g.,made of Nitinol), may be used to connect to the suture and be passed bythe tissue penetrator which can grab the capture element in order tomake a complete circle around a tear. The capture element, connected tothe suture, would then shuttle a suture in its place through the tissue.

FIG. 34A shows an example of a suture passer that may be used, with thetissue penetrator extended. The tissue penetrator may be similar to thatshown in FIGS. 5A-6D. In some variations the tissue penetrator isadapted to hold and release a capture element coupled to a suture in thelower jaw, and to allow the capture element to expand when released intothe upper jaw. FIGS. 34B-34G are simplified illustrations of a method offorming a loop of suture around a tear in a meniscus (lateral tear3409). For simplicity, the upper and lower jaws (which are extendedaround the meniscus) are not shown in FIGS. 34B-34G, although thesuture, collapsible capture element and tissue penetrator are shown. InFIG. 34B, the suture passer is preloaded with the expandable captureelement, and pushes it through the meniscus, from the inferior to thesuperior side. Once passed, the tissue penetrator retracts back throughthe meniscus to the lower jaw, and the collapsed capture element is freeto expand. In FIGS. 34B-34G the capture element is a loop of wire thatis biased open; as the tissue penetrator retracts back to the lower jaw,as shown in FIG. 34C, the loop expands open on the superior side of themeniscus. The capture element in this example is large enough to expandacross the tear in the meniscus; the anatomical constraints of thetissue around the meniscus allow the expandable capture element toexpand only on the superior surface in the predictable direction.Because the tissue penetrator pushed distally (up the superior surfaceof the meniscus) the loop expands in this direction. Re-orienting thesuture passer may allow it to direct how and where the expandablecapture element expands.

In FIG. 34D, the suture passer has been repositioned relative to thetear in the meniscus, so that the tissue penetrator may pass on theopposite side of the tear, as illustrated. The tissue penetrator extendsout of the superior side of the meniscus and though the loop of thecapture element. In FIG. 34E, the proximal end of the suture (which isattached distally to the capture element) is pulled proximally totighten the loop around the tissue penetrator. The tissue penetrator isthen retracted, pulling the capture element with it, as shown in FIG.34F. As the capture element is drawn through the tissue, it againcollapses. Once it has been withdrawn through the tissue, pulling thesuture behind it, the capture element may be removed, and the ends ofthe suture secured, as shown in FIG. 34G.

In the example shown in FIGS. 34A-34G, a single tissue penetrator isshown placing the loop and then retrieving the loop. An alternativeembodiment could have a lower jaw that contains two tissue penetrators(e.g., needles), one for placing the loop and another for retrieving theloop. Additionally, a third embodiment could contain two independentlower jaws, each containing its own needle. As in the second embodiment,one needle would place the loop and the other needle would retrieve theloop. By placing the needles in separate lower jaws, the two lower jawscould be independently actuated to allow the surgeon to adjust thedistance between the two vertical legs of the stitch.

FIG. 35A shows one variation of an expandable capture element that isconnected to a suture. In this example, the expandable capture elementis configured as a nickel-titanium (e.g., Nitinol) wire that forms aloop but is biased in the open configuration. The suture 3503 isconnected to the loop 3501 (either directly or through a leader); forexample, the suture may be tied to the flexible loop. FIG. 35B showsanother variation of an expandable capture element, configured as aplurality of loops 3506 that are flexible but biased open (expanded). Asuture 3503 may be affixed to the plurality of loops (“basket”) 3506.The plurality of loops may help ensure that the tissue penetrator hook(e.g., pulling hook) catches the capture element; this feature mayalleviate the need to cinch the suture (e.g., pull the sutureproximally).

In some variations the expandable capture element is not extendedsubstantially from the upper jaw member, but remains within the jawmember and is held by the upper jaw member after withdrawing the tissuepenetrator so that when the tissue penetrator is again extended throughthe jaw, the tissue penetrator will pass through it, and the captureelement can be pulled onto the tissue penetrator to engage with it sothat it can be withdrawn back through the tissue.

FIGS. 36A-36C illustrate this variation. In FIG. 36A, the tissuepenetrator has an upper jaw member that includes a holding region 3605for the capture element; in FIG. 36A, the holding region is defined onthe underside of the upper jaw by a retaining plate 3605, as alsoillustrated in FIG. 36B. The Nitinol loop 3601 is pushed by the needleso that the expandable capture element expands into the space under theupper jaw defined by the plate, as shown in FIG. 36B. The holding regionmay be defined by the upper jaw so that the capture element (e.g., loop)is held with an orientation that prevents the capture element fromengaging with the needle when it is pushed fully distally. FIG. 36Cshows a section through the holding region of the upper jaw, where acapture element 3601 is being held. After retracting the needle andrepositioning the device, the needle/tissue penetrator can again beextended through the tissue and into the upper jaw, as shown in FIG.36D. The needle may pass through the loop of the capture element held inthe upper jaw. The suture may then be pulled proximally, reorienting thecapture element and pulling it onto the needle so that it engages theneedle and is pulled back through the tissue when the needle iswithdrawn back though the tissue. This is illustrated in FIG. 36E(showing cinching of the loop of the capture element) and FIGS. 36F-36H,showing the capture element being withdrawn back to the lower jaw. InFIG. 36E, the suture 3603 is pulled to cinch the loop of the captureelement onto the needle. In FIGS. 36F and 36G, the needle 3615 is showncapturing the loop of the capture element 3601. Finally, FIGS. 36H and36I show the tissue penetrator completely withdrawn (holding the captureelement) into the lower jaw (FIG. 36H), and the device being withdrawnfrom the tissue, as shown in FIG. 36I, which pulls the rest of thecollapsed loop from the meniscus, and pulls the suture into position.

FIGS. 37A and 37B illustrate variations on the interaction between thecapture element and the tissue penetrator. In FIG. 37A, the tissuepenetrator couples with a loop of the capture element; thus the flexibleloop can be preloaded onto the tissue penetrator before it is retractedinto the lower jaw and primed to “fire” across the tissue. In somevariations it may be beneficial to have the capture element be coupledto the tissue penetrator via a loop of suture material or other materialthat does not self-expand, such as the expandable capture element does.This may help with pre-loading the capture element onto the tissuepenetrator, and may also help in reducing the force needed to pass thecapturing element through the tissue. FIG. 37B illustrates one examplein which a loop of suture is connected to the capture element that isalso connected to a length of suture, as shown.

Enhancing Suturing Accuracy

Although the suture passers described herein may be used to pass suturesthough tissue (and particularly meniscal tissue) having variousthicknesses and dimensions by adjusting the bite (e.g., the angulardistance between the upper and lower distal-facing jaws), adjusting thebite size may change the contact position of the needle/tissuepenetrator as it extends from the lower jaw to the upper jaw. Note thatin any of the variations described herein, the lower jaw may refer toeither the first jaw or second jaw, as the orientation may be relative;similarly the upper jaw may refer to the opposite jaw, in anyorientation. Although the devices describe herein are configured so thatthe devices tolerate changes in the contact point between the needle andthe upper jaw, while still deflecting the needle distally as describedabove, it may be beneficial to know where on the upper jaw the needlewill exit the tissue and contact the upper jaw. This may be referred toas targeting. It may be relatively less certain where the needle mayexit the tissue when the bite size of the needle is smaller (e.g., whenthe jaws are more closed).

Described herein are methods and devices that allow the user to place astitch in an intended location even when the jaws are relatively“closed” (e.g., small bite size), as when passing a suture in the morecentral regions of the meniscus. This uncertainty does not typicallyarise when placing a stitch at the periphery of the meniscus, when thebite size is relatively large, because the user can position the deviceas distal as it will go and blindly fire (see FIG. 38A). However, thewhen a stitch is placed on the middle of the meniscus or near the apexof the meniscus (see FIG. 38B), it is less certain where the needle mayexit the tissue relative to the upper jaw. FIG. 38A shows the placementof a stitch near the periphery of a meniscus. A user can just pushdevice past the tear and deliver stitch without worrying about accuracyof where the needle will contact the upper jaw. FIG. 38B shows a stitchnear the apex of the meniscus. The surgeon is placing a stitch betweenthe tear and the apex. However if the stitch is placed too close to theapex, the stitch won't grab enough tissue to be secure, too close to thetear and the stitch could be sent up through the tear. When the deviceis placed in a joint, such as the knee joint, the lower jaw may becompletely covered by tissue, and the needle exit is invisible to theuser. A stationary mark on the upper jaw is problematic because it maynot predict where the needle with exit/hit; the needle may hit the upperjaw in different locations based on clamp height.

Described below are methods and device (e.g., adaptations to devices)that may be used to target stitch placement.

In some variations the lower (sliding) jaw is configured to moveconjugally with the clamping of the upper jaw, so as to maintain anapproximate relative striking distance between the tissue penetrator andthe upper jaw when passing the tissue penetrator across the jaws.

FIG. 39A shows a jaw moving though a large tissue thickness (e.g., athick meniscus in this example). An exemplary “thick” tissue thicknessmay be 7.5 mm. At this size thickness, the needle will hit the upper jawat a given location shown in FIG. 39A by the “X” 3905. Without conjugatemotion between the upper and lower jaw (e.g., moving the lower jawdistally/proximally as the upper jaw bends to change the bite angle),the location of this contact point will vary, as illustrated by the moreproximal contact point “o” 3909 in FIG. 39B. If, however, when the upperjaw clamps down, the lower jaw would move forward 3911, the contactpoint may be corrected to ensure that the needle hits the upper jaw inthe same location, 3907. In this example, the lower jaw may move to theleft 3911, relative to the shaft, to deliver the suture to the “X”target on the upper jaw 3907.

Thus, the suture passer may be configured as described above so that thelower jaw can be moved axially (distally/proximally relative to theelongate axis), both independently (to form the distal-facing opening,and also in conjugate motion when clamping/unclamping the upper jaw tochange the bite angle of the suture passer.

In some variations, the movement of the upper jaw and the conjugatemotion of the lower jaw can both be controlled by the clamp trigger(refer to FIGS. 5A-5B, for example). As the upper jaw clamps down, theaxial distance of the “X” may move at a nonlinear rate distally. Inorder for the lower jaw to match that axial distance, it may also travelat the same rate. This can be accomplished by having the lower jawmotion controlled by a cam profile on the needle trigger. An example ofsuch a cam profile is shown in FIG. 40 .

In FIG. 40 , the lower jaw include a cam follower 4005 that includes acamming surface that may also drive axial motion of the lower jaw whenthe upper jaw is moved. In this manner, motion of the upper jaw may beconfigured so that the axial position is adjusted based on the angle ofthe upper jaw with the elongate, long axis, of the device. The lower jawmay still be manually and independently axially movable toextend/retract axially. In some variations the lower jaw moved inconjugate motion with the upper jaw only when the lower jaw member isfully extended first (e.g., manually fully extended). Further, in somevariations the conjugate motion between the upper jaw member and thelower jaw member may be turned “on” or “off” for the device.

Also described herein are methods and devices for informing a user wherethe tissue penetrator may be passing through the tissue. As discussedabove, it may be advantageous to provide an indicator to the operator ofwhere the tissue penetrator (e.g. needle) will exit the tissue. In somevariations the device may include an optical marking element (e.g.,light) that indicates on the tissue and/or on the device, such as theupper jaw of the device, where the tissue penetrator will exit thetissue or where it will contact the upper jaw. FIG. 41 illustrates onvariation of a device including an optical fiber 4103 extending with(and part of) the lower jaw that project a spot of light (e.g., visibleor visualizable light) through the tissue. This light may be from anLED, laser, or other appropriate source. For example, a light source isplaced on the lower jaw pointing toward the upper jaw to indicate wherethe needle will exit. In thin sections of tissue, if the light is strongenough, there should be a visible spot on top of the tissue that theuser can use to place the stitch with confidence.

Tactile/Audible Feedback

Also described herein are devices configured to provide tactile and/oraudible feedback to the user that the lower jaw and/or needle have beenfully extended. For example, for certain suture passers, the grip forcerequired to actuate the needle may be great enough that it is difficultfor the user to feel the needle trigger's end of travel because theactuation force already placed high demands on the user's grip strength.Thus, it is hard for the user to detect that they are pushing up againstsomething immovable, the travel limiter, because the force required toactuate the needle trigger feels may be great. In these cases, a suturepasser device that provides an audible “click” or some other cue ishelpful to the surgeon to ensure that he or she has fully actuated thedevice. For suture passers with slightly lower actuation forces,coupling the audible feedback with tactile feedback, whereby the surgeonfeels a click or a detent just prior to the needle trigger hitting itstravel limiter, could provide additional assurance to the user that heor she has properly completed actuation.

One method for providing both an audible and tactile cue is shown inFIG. 42A. FIG. 42A shows a cutaway view of the suture passer handlemechanism. In this example, the needle driver 4209 is rigidly attachedto the needle (not shown). As the surgeon grips the needle trigger 4205,the needle driver 4209 translates forward. Because it is rigidlyattached to the needle driver, the needle also translates forward as theneedle trigger is gripped.

The needle driver contains a boss that, as it moves past a clickingelement 4207, bends the Clicking Element upward as shown in FIG. 42B.Once the boss has moved distally past the interfering portion of theclicking element, the clicking element is free to snap back down whereit impacts a feature 4215 on the handle (see FIG. 42C). This impact isenough to create an audible click that can also be felt in the user'shand.

Any other appropriate feedback actuator for providing audible and/ortactile feedback at or near the maximum extension of the needle and/orlower jaw may be used. The configuration described above in FIG. 42 is amechanical feedback actuator; in some variations the system may use oneor more optical encoders and a piezo or other electronic technique forproviding feedback to the user (e.g., electrical feedback actuator).

Upper Jaw Shape

Any of the devices described herein may include an upper jaw that isadapted to fit within the confines of a joint such as the knee. Forexample, the upper jaw, which may be hinged relative to an elongate bodyof the suture passer, as described above, may be radiused (e.g., curved)upwards slightly, particularly over the proximal region of the upperjaw, near the hinge connection. FIG. 48A illustrates one variation of anupper jaw having an upwards curvature 4815 on the outer/upper surface.In the context of the knee joint, this upper jaw member (which may alsobe referred to as an upper jaw or upper arm) may match the curvature ofthe femoral region of the joint surrounding the meniscus. Examples ofupper jaws including radiused outer surfaces may be see in FIGS. 1A, 1B,3A, 15A-E, 26C-I, and 29B, for example.

Thus, the upper jaw of a suture passer adapted for passing suture in theknee around the meniscus may be shaped for joint access such that thesuperior (upper) surface of the upper jaw has a gentle curve thatapproximates the curvature of the femoral head, as shown in FIG. 48A. Anupper jaw with this shape can be easily inserted into the knee jointspace so that the upper jaw is superior to the meniscus in order tofacilitate suture passing. However, one potential disadvantage of anupper jaw with the shape shown in FIG. 48A is that the convex surface onthe inferior side (inner, tissue-contacting surface) may have help pushthe meniscus distally out of (and away from) the distal-facing openingbetween the jaws when the upper and lower jaws are closed over themeniscal tissue, as discussed above in reference to FIGS. 38A-39B. Thisphenomena is disadvantageous when trying to pass a tissue penetrator(e.g., needle) through the meniscus in a precise manner, as it can causethe meniscus to be displaced out of the jaws, and/or may cause theneedle to miss the suture retention feature in the upper jaw.

Although this issue may be addressed, at least in part, by the conjugatemotion of the upper and lower jaws described above, a modified versionof the upper jaw, having a flat or less curved inferior(tissue-contacting) surface may also address this issue. For example,FIG. 48B shows an upper jaw having a geometry with a straighter profile4813 in its proximal region (near the hinge). The proximally straightvariation shown in FIG. 48B may have a significantly lower propensityfor pushing the meniscus out of the distal-facing mouth formed by theupper and lower jaws when the closing the jaws around the tissue, whichmay help keep the meniscus from being displaced when passing a suturewith the device, improving locational precision and suture capturereliability. Unfortunately, this configuration may not be optimallyshaped for joint access, because of the overhead constraint of the femurand the lower “slope” of a straight upper jaw. Thus, the distal tip ofthe upper jaw may be less able to clear the meniscus on the superiorside as easily as the radiused outer surface. The differences betweenthe proximally curved upper jaw of FIG. 48A and the proximally straightupper jaw of FIG. 48B are shown in FIG. 48C, showing both upper jawgeometries overlaid on top of each other. In FIG. 48B, the superiorsurface of the straight upper jaw 4803 is opposite the inferior curvedsurface of the radiused 4805 upper jaw. When looking at the overlay, thesuperior surface of the proximally straight upper jaw variation maycontact the femoral head sooner than the superior surface of theproximally curved jaw variation. However, when the proximally straightjaw variation contacts the femoral head, its distal end is not as high,and may have less ability to clear a tall meniscus.

FIG. 48D shows a side view of a hybrid upper jaw having both aradiused/curved proximal superior surface 4815 and a straight (or lesscurved relative to the superior surface) inferior, tissue-contactingsurface 4813. In this example, the upper jaw has a thinner proximalregion (between the hinge 4819 and the distal region 4820.

The hybrid upper jaw shape adapts the proximally radiused superiorsurface with the relatively straight inferior (lower) surface; using theprofile of the curved upper jaw shown in FIG. 48A for the superiorsurface and the distal half of the inferior surface, and the inferiorprofile of the proximally straight upper jaw shown in FIG. 48C. Thishybrid profile combines the excellent access shape along with thefeatures necessary to mitigate the probability that the meniscus ispushed peripherally during clamping.

Thus, any of the suture passers described herein may have hinged upperjaw extending in a proximal to distal axis, with a hinge region at ornear the proximal end. The upper jaw may have an outwardly curved(radiused) superior surface extending distally from the hinge region.The inferior, tissue-contacting, surface opposite this outwardly curvedsuperior surface may be configured to extend straight in the proximal todistal axis. Thus, the thickness of the upper jaw as it extends from thehinge region distally may be narrower (thinner) more proximally thandistally, as shown in FIG. 48D.

Asymmetric Needles

The tissue penetrators (needles) described herein typically have a sharpdistal tip that is adapted to penetrate tissue. The sharp distal tip maybe located anywhere along the width of the tissue penetrator. Forexample, the sharp distal tip may be centered relative to the width, asshown in FIG. 7A, or it may be laterally offset from the midline of thetissue penetrator (where the midline extends in a proximal to distaldirection).

In some variations, it may be desirable to have the sharp distal tipregion laterally offset from the midline of the width, as illustrated inFIG. 49A. In particular, in variations in which the jaw member in whichthe tissue penetrator is housed include a longitudinal suture loadingchannel (as shown and described in FIGS. 18A-18E, above). However, aneedle having a centered sharp distal tip may snag or catch on thesuture when loading the suture into the central channel. For thisreason, a laterally offset sharp distal tip (as shown in FIGS. 18A and37A-37B) may be used. An asymmetric needle tip offers advantages forloading suture when there is a central suture loading channel in thelower jaw, because having the needle tip off to one side of the loadinggroove may ensure that the sharp tip of the needle is not exposed to thesuture, mitigating the chances that the suture will snag on the needletip, as shown in FIG. 49A. The central suture-loading channel 4907 inthe jaw 4916 is continuous with a suture holding region 4901 and theentire channel (and thus any suture held within the channel) isprotected from the sharp distal tip 4905, as the sharp distal tip 4905of the tissue penetrator 4903 is laterally displaced and is held withinthe jaw 4916.

Unfortunately, asymmetric needle tips may have a tendency to driftlaterally (e.g., toward the side of the needle tip) when passing throughtissue, because the force of driving the needle through the tissueresults in a normal force on the angled needle edge. With enough needledrift, the needle can miss the suture retention feature in the oppositejaw, as shown in FIG. 49B. In FIG. 49B, the tissue penetrator has asharp distal tip that is laterally offset from the midline of the width,similar to the needle 4903 shown in FIG. 49A. The tip of the needle 4905has drifted (been driven) lateral to the opposite jaw 4918.

In general, tissue penetrators having less asymmetrically located sharpdistal tips (e.g., less laterally offset from the midline) may have lessof a tendency to deviate laterally when extending through the tissue,and may therefore have a higher reliability when contacting the sutureretention feature in the opposite jaw. However, to ensure that suturecan enter the loading area of the suture passer without snagging on theneedle tip, the shape of loading channel may be modified to cover theneedle tip. For example, FIG. 49C illustrates one variation of a jawhaving a central suture loading channel 4907 to load a suture into atissue penetrator. The jaw includes a ramped cover 4911 housing thecentrally (or slightly offset from the midline, e.g., less than 30%offset, less than 25% offset, less than 20% offset, less than 15%offset, etc. from the midline) located sharp distal tip 4905′ of thetissue penetrator 4903′. Thus, a suture may be protected from snaggingon the tissue penetrator tip when being loaded in the central channel4907.

Any of the tissue penetrators described herein may also be adapted toprevent snagging of tissue (e.g., capsule or meniscal tissue) whenextending through the tissue.

FIG. 50A illustrates one variation of a tissue penetrator (needle)having a side-opening suture retainer region 5005. The distal edge 5003of the side opening 5005 extends the full lateral width of the tissuepenetrator, w, as shown in FIG. 50A, as does the proximal edge 5002 ofthe side opening 5005 of the suture retainer region 5001.

When a surgeon is passing a suture through meniscus using a suturepasser, the surgeon may wish to pass suture through the adjoiningcapsular tissue as well. The capsular tissue behaves much differentlythan meniscal tissue, and may have a high propensity for snagging onneedle features rather than being punctured by the needle tip.Consequently, needle tip sharpness may be important; unfortunately, evenif the tip of the needle is sharp other portions of the needle, andparticularly the side opening suture retaining region may get caught oncapsular tissue, impeding the forward motion of the tissue penetrator.FIG. 50B illustrates one example of a needle such as the needle shown inFIG. 50A extending though a meniscus and capsule; the capsule tends tocollapse around the needle as the needle is extended distally, drivingthe capsule tissue into the suture retainer region and hooking it on theproximal side of the suture retainer region. This can potentiallydeflect the tissue penetrator or prevent it from advancing furtherdistally.

To ensure that a needle can easily pass through the tissue, a needle maybe adapted to prevent snagging by providing angled surfaces, so that anytissue being directed medially inwardly (e.g., into the suture retainingregion) is directed laterally out of the suture retainer region.

For example, FIG. 50C show one variation of a tissue penetrator that hasthe proximal edge of the side opening for the suture retainer regionforms a ramping region 5007 (e.g., an angle relative to the proximallong side of the needle) that is between about 100 degrees and 170degrees (e.g., in FIG. 50C, the angle, α, is approximately 135 degrees,as shown in FIG. 50D) and has a ramp length that is sufficiently long toallow tissue to contract around the needle slightly but still land onthe ramp region and be guided out of the suture retainer region. Theramp length may be between about 5% and about 50% (e.g., between 10% and40%, between about 10% and 35%, etc.) of the width of the needle, w. InFIG. 5C, the length of the ramp 5007 is approximately 20% the width ofthe needle. In FIG. 50C, the proximal edge of the opening for the sutureretainer region has a ramp shape near the proximal edge that moves thetallest point of the suture retention feature on the needle closer tothe midline of the needle and away from the side. By moving this featureinward (forming the ramp region), there is less chance that tissue cansnag on this location.

Any of the suture passers described herein could be used for repair ofsoft tissue in joints, to sew in allografts or artificial soft tissueconstructs such as an artificial meniscal scaffold or graft, and/or formeniscus repair.

Although many of the variations of suture passer devices describedherein are configured so that the tissue penetrator extends distallyfrom an opening in a jaw, any of the suture passers described herein maybe configured so that the tissue penetrator extends proximally afterextending between the upper and lower jaws. Thus, the deflectionfeatures on the upper jaw could be set to facilitate the needle headingin the proximal direction. For example, in some variations the tissuepenetrator extends proximally within (or out of) the upper jaw memberafter extending across the opening between the jaws.

Although the description above is broken into parts and includesspecific examples of variations of suture passers, any of the featuresor elements described in any particular example or section may beincorporated into any of the other embodiments. Although the foregoinginvention has been described in some detail by way of illustration andexample for purposes of clarity of understanding, it is readily apparentto those of ordinary skill in the art in light of the teachings of thisinvention that certain changes and modifications may be made theretowithout departing from the spirit or scope of the appended claims.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A replaceable jaw cartridge that is preloaded with suture, for selective coupling with a suture passer device, the jaw cartridge comprising: a lower jaw region at a distal end, a suture storage capsule at a proximal end and an elongate track region therebetween; a tissue penetrator configured to slide distally and proximally within the jaw cartridge along the lower jaw region; a suture defining a first end, a second end and an intermediate length therebetween, the suture first end and second end forming a first and second suture bight respectively, both suture bights disposed in the lower jaw region, the intermediate length disposed along the elongate track region and stored within the suture storage capsule; and a sled at least partially covering a length of the elongate track region and operatively coupled to the tissue penetrator and configured to selectively couple to the suture passer device to slide the tissue penetrator, the sled also configured to pinch the second end of the suture extending from the lower jaw region between the sled and tissue penetrator.
 2. The replaceable jaw cartridge of claim 1 wherein the sled is configured to releasably pinch the second end of the suture so that a portion of the suture is held loosely within the lower jaw region when the tissue penetrator is extended distally but the portion of the suture is in tension when the tissue penetrator is withdrawn proximally so that the second bight is loaded into a suture engagement region of the tissue penetrator after the first bight has been removed from the suture engagement region.
 3. The replaceable jaw cartridge of claim 1 wherein the lower jaw region includes a cover to retain the suture first end and second end therein.
 4. The replaceable jaw cartridge of claim 1 wherein the elongate track region includes a first bilateral flange adjacent the lower jaw region and a second bilateral flange proximally spaced from the first bilateral flange, the first and second bilateral flanges configured to be keyed to complementary engagement regions on the suture passer for securing the suture passer and the replaceable jaw cartridge together.
 5. The replaceable jaw cartridge of claim 1 wherein the suture storage capsule further comprises an opening for operatively engaging with a retainer within a handle of the suture passer.
 6. The replaceable jaw cartridge of claim 5 wherein when the suture storage capsule is operatively engaged with the retainer, the suture storage capsule is at least partially disposed within a housing of the handle.
 7. The replaceable jaw cartridge of claim 1 wherein the sled is configured to pinch the second end of the suture at two locations, axially spaced from each other.
 8. A suture passer system with a preloaded suture, the system comprising: a durable portion including an elongate body extending distally and proximally, a handle at a proximal end and a first jaw at a distal end of the elongate body; and a replaceable jaw cartridge that is preloaded with suture, for selective coupling with the durable portion, the replaceable jaw cartridge comprising: a lower jaw at a distal end, a suture storage capsule at a proximal end and an elongate track region therebetween; a tissue penetrator configured to slide distally and proximally within the replaceable jaw cartridge along the elongate track region; a suture defining a first end, a second end and an intermediate length therebetween, the suture first end and second end forming a first and second suture bight respectively, both suture bights disposed in the lower jaw region, the intermediate length disposed along the elongate track region and stored within the suture storage capsule; wherein the elongate track region includes a first bilateral flange adjacent the lower jaw region and a second bilateral flange proximally spaced from the first bilateral flange, the first and second bilateral flanges configured to be keyed to complementary engagement regions on the durable portion for coupling the replaceable jaw cartridge to the durable portion.
 9. The suture passer system of claim 8 wherein the replaceable jaw cartridge also includes a sled at least partially covering a length of the elongate track region and operatively coupled to the tissue penetrator to axially slide the tissue penetrator, the sled also configured to releasably pinch the second end of the suture extending from the lower jaw between the sled and the tissue penetrator.
 10. The replaceable jaw cartridge of claim 9 wherein the sled is configured to releasably pinch the second end of the suture so that the second end is held loosely within the lower jaw when the tissue penetrator is extended distally but the second end is in tension when the tissue penetrator is withdrawn proximally so that the second bight is loaded into a suture engagement region of the tissue penetrator after the first bight has been removed from the suture engagement region.
 11. The replaceable jaw cartridge of claim 9 wherein the sled is configured to pinch the second end of the suture at two locations, axially spaced from each other.
 12. The replaceable jaw cartridge of claim 8 wherein the lower jaw includes a cover to retain the suture first end and the suture second end therein.
 13. The replaceable jaw cartridge of claim 8 wherein the suture storage capsule further comprises an opening for operatively engaging with a retainer within the handle of the durable portion.
 14. The replaceable jaw cartridge of claim 13 wherein when the suture storage capsule is operatively engaged with the retainer, the suture storage capsule is at least partially disposed within a housing of the handle. 